EXECUTION VERSION

CONFIDENTIAL

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

Exhibit 10.2

AMENDED AND RESTATED

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

(for the US and Certain Other Territories)

between

FIBROGEN, INC.

and

ASTRAZENECA AB

 

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TABLE OF CONTENTS

 

ARTICLE 1 Definitions

2

 

 

ARTICLE 2 Collaboration; Governance

17

 

 

ARTICLE 3 Development

27

 

 

ARTICLE 4 Regulatory Matters

35

 

 

ARTICLE 5 Commercialization

37

 

 

ARTICLE 6 Manufacture and Supply

42

 

 

ARTICLE 7 Licenses And Exclusivity

46

 

 

ARTICLE 8 Financials

52

 

 

ARTICLE 9 Intellectual Property

65

 

 

ARTICLE 10 Representations And Warranties

73

 

 

ARTICLE 11 Indemnification

79

 

 

ARTICLE 12 Confidentiality

81

 

 

ARTICLE 13 Term and Termination

85

 

 

ARTICLE 14 Dispute Resolution and Governing Law

90

 

 

ARTICLE 15 Miscellaneous

92

 

 

Exhibit A – Territory – Excluded Countries

1

 

 

Exhibit B – DFCI Agreement

1

 

 

Exhibit C – Chemical Structure of FG-4592

1

 

 

Exhibit D – Field Indications

1

 

 

Exhibit E – Listed Patents

1

 

 

Exhibit F – AstraZeneca’s Anti-Corruption Rules and Policies

1

 

 

Exhibit G – Initial Members of the JSC

1

 

 

Exhibit H – Initial Development Plan

1

 

 

Exhibit I – U.S. Co-Commercialization Terms

1

 

 

Exhibit J – Development Supply Terms

1

 

 

Exhibit K – Commercial Supply Terms

1

 

 

Exhibit L – Invoicing Requirements

1

 

 

Exhibit M – Patents that May be Extended

1

 

 

Exhibit N – Joint Press Release

1

 

 

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

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AMENDED AND RESTATED

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This Amended and Restated License, Development and Commercialization Agreement
(the “Agreement”) is entered into as of October 16, 2014 (the “Execution Date”),
and effective as of July 30, 2013 (the “Effective Date”) by and between
FibroGen, Inc., a Delaware corporation having its principal place of business at
409 Illinois St., San Francisco, California 94158, United States (“FibroGen”)
and AstraZeneca AB, a company incorporated in Sweden under no. 556011-7482 with
offices at Pepparedsleden 1, 431 83 Mölndal, Gothenburg, Sweden
(“AstraZeneca”).  FibroGen and AstraZeneca are sometimes referred to herein
individually as a “Party” and collectively as the “Parties”.

Background

A.AstraZeneca is a fully-integrated, global pharmaceutical company with
expertise in the research, development, manufacture and commercialization of
human therapeutic products.

B.FibroGen is a biotechnology company with expertise in the discovery, research,
development and manufacture of small molecule prolyl hydroxylase inhibitors that
modulate hypoxia-inducible factor for the treatment of anemia.

C.FibroGen is developing certain of such compounds in collaboration with
Astellas Pharma Inc. (“Astellas”), its exclusive licensee for Japan, Europe, the
Commonwealth of Independent States (CIS), the Middle East and South Africa
pursuant to certain collaboration agreements between FibroGen and Astellas
(collectively, the “Astellas Collaboration”).

D.AstraZeneca and FibroGen desire to establish as of Effective Date a
collaboration for the joint continued development, including regulatory
submission, and, if successful, commercialization of certain of such compounds
in the U.S. and all countries of the world other than those subject to the
existing Astellas Collaboration.

E.With respect to the collaboration between the Parties in China, the
development and commercialization activities are governed by that certain
License, Development and Commercialization Agreement (China) by and between
FibroGen China Anemia Holdings, Ltd., Beijing FibroGen Medical Technology
Development Co., Ltd., and FibroGen International (Hong Kong) Limited,
Affiliates of FibroGen, and AstraZeneca, of even date herewith (the “China
Agreement”), except that a portion of the governance structure for China shall
be as set forth in this Agreement, and the Parties’ activities with respect to
all other countries not licensed to Astellas are governed by this Agreement.

1.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

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Now, Therefore, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Agreement, the Parties
agree as follows:

ARTICLE 1

Definitions

As used in this Agreement, the following initially capitalized terms, whether
used in the singular or plural form, shall have the meanings set forth in this
Article 1.  Except where the context otherwise requires, the use of any gender
shall be applicable to all genders and the word “or” is used in the inclusive
sense (and/or).  Whenever this Agreement refers to a number of days, unless
otherwise specified, such number refers to calendar days.  In addition, the
terms “includes,” “including,” “include” and derivative forms of them shall be
deemed followed by the phrase “without limitation” (regardless of whether it is
actually written there (and drawing no implication from the actual inclusion of
such phrase in some instances after such terms but not others)).

1.1“Acquiror” has the meaning set forth in Section 15.5.

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

1.3“Alliance Manager” has the meaning set forth in Section 2.7.

1.4“Annual Net Sales” means the Net Sales made during any given Calendar Year.

1.5“Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as
amended, the UK Bribery Act 2010, as amended, and any other applicable
anti-corruption laws and laws for the prevention of fraud, racketeering, money
laundering or terrorism.

1.6“Astellas” has the meaning set forth in Section C on the first page.

1.7“Astellas Agreements” means the Astellas EU Agreement and the Astellas Japan
Agreement.

1.8“Astellas Collaboration” has the meaning set forth in Section C on the first
page.

1.9“Astellas EU Agreement” means the Anemia License and Collaboration Agreement
between FibroGen and Astellas with respect to the countries listed on Exhibit A
(other than Japan) effective April 28, 2006, as amended from time to time.

2.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

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1.10“Astellas Japan Agreement” means the Collaboration Agreement between
FibroGen and Astellas with respect to Japan effective June 1, 2005, as amended
from time to time.

1.11“AstraZeneca Inventions” has the meaning set forth in Section 7.8(d).

1.12“AstraZeneca Know-How” means all Information Controlled as of the Effective
Date or thereafter during the Term by AstraZeneca and/or its Affiliate(s) that
is reasonably necessary or useful for the research, development, manufacture,
use, importation or sale of Products in the Field.  For clarity, the use of
“Affiliate” in this definition shall exclude any Third Party that becomes an
Affiliate due to such Third Party’s acquisition of or by AstraZeneca, except as
provided in Section 15.5.  For additional clarity, AstraZeneca Know-How shall
exclude rights under any AstraZeneca Patents and AstraZeneca’s interest in the
Joint Patents and Joint Inventions.

1.13“AstraZeneca Patents” means all Patents that are Controlled as of the
Effective Date or thereafter during the Term by AstraZeneca and/or its
Affiliate(s) and that claim the composition of matter, manufacture or use of one
or more Collaboration Compounds or Products or that would otherwise be infringed
(or with respect to patent applications, would be infringed if issued or granted
with the then-currently pending claims), absent a license, by the manufacture,
use or sale of any Collaboration Compounds or Product.  For clarity, the use of
“Affiliate” in this definition shall exclude any Third Party that becomes an
Affiliate due to such Third Party’s acquisition of or by, AstraZeneca except as
provided in Section 15.5.

1.14“AstraZeneca Anti-Corruption Rules and Policies” means the key principles
from AstraZeneca’s ABAC and External Interactions Policies regarding
anti-bribery and corruption issues, attached as Exhibit F to this Agreement, as
the same may be amended, modified or supplemented from time to time as notified
by AstraZeneca to FibroGen.

1.15“AstraZeneca Technology” means the AstraZeneca Patents, AstraZeneca
Know-How, and AstraZeneca’s interest in Joint Patents and Joint Inventions.

1.16 “Bankrupt Party” has the meaning set forth in Section 13.9(b).

1.17“Business Day” means a day other than a Saturday, Sunday or bank or other
public holiday in San Francisco, California, the UK or Sweden.

1.18“Calendar Quarter” means each successive period of three (3) calendar months
commencing on January 1, April 1, July 1 and October 1.

1.19“Calendar Year” means each successive period of twelve (12) calendar months
commencing on January 1.

1.20“Carcinogenicity Studies” means the following carcinogenicity studies in
rats and mice: (1) [ * ].

1.21“China Agreement” has the meaning set forth in Section E on the first page.

3.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

CONFIDENTIAL

 

1.22“China Committee” means the governing committee established under the China
Agreement, and any successor or other committee or governing body that serves
the same functions under the China Agreement.

1.23“CKD Indications” means (a) treatment of anemia in patients with chronic
kidney disease undergoing dialysis, and (b) treatment of anemia in patients with
chronic kidney disease not undergoing dialysis.

1.24“Clinical Trial” means any human clinical trial of a Product.

1.25“Co-Commercialization Agreement” has the meaning set forth in Section 5.10.

1.26“Collaboration” has the meaning set forth in Section 2.1.

1.27“Collaboration Compound” means any of the following: (a) FG-4592, (b) any
HIF Compound (other than FG-4592) that is added to this Agreement pursuant to
Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and
amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers),
prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or
(b)).

1.28“Collaboration Inventions” has the meaning set forth in Section 9.2.

1.29“Combination Product” means a Product that is comprised of or contains a
Collaboration Compound as an active ingredient together with one (1) or more
other active ingredients and is sold either as a fixed dose/unit or as separate
doses/units in a single package.

1.30“Commercialization” means the commercial manufacture, marketing, promotion,
sale and/or distribution of Products in the Territory.  Commercialization
includes commercial activities conducted in preparation for Product launch in
each indication.  “Commercialize” has a correlative meaning.

1.31“Commercialization Costs” means all costs incurred by or on behalf of
FibroGen that are directly and reasonably allocable to the conduct of activities
allocated to FibroGen under the U.S. Commercialization Plan or
Co-Commercialization Agreement for the Commercialization of Products in the U.S.

1.32“Commercially Reasonable Efforts” means, with respect to a Party’s
obligations under this Agreement to Develop or Commercialize a Product, the
carrying out of such obligations or tasks with a level of efforts and resources
consistent with the commercially reasonable practices of (a) in the case of
AstraZeneca, a pharmaceutical company the size and geographical scope of
AstraZeneca and (b) in the case of FibroGen, a biotechnology company the size
and geographical scope of FibroGen, in each case (a) and (b) for the development
or commercialization of similarly situated pharmaceutical products as such
Product and at a similar stage of development or commercialization, taking into
consideration their safety and efficacy, their cost to develop, the nature and
extent of their market exclusivity (including patent coverage and regulatory
exclusivity), the likelihood of Regulatory Approval, their expected
profitability, including the

4.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

CONFIDENTIAL

 

amounts of marketing and promotional expenditures with respect to such products
and generic products, and the competitiveness of alternative compounds and
products.  Commercially Reasonable Efforts requires that the Party: (a) promptly
assign responsibility for such obligations or tasks to specific employee(s) who
are held accountable for progress and monitor such progress on an on-going
basis, (b) set and consistently seek to achieve specific and meaningful
objectives for carrying out such obligations, and (c) consistently make and
implement decisions and allocate resources designed to advance progress with
respect to such objectives.  For the avoidance of doubt, the commitment to use
“Commercially Reasonable Efforts” shall not preclude the suspension or
discontinuance by AstraZeneca of any Product, if appropriate, based on the
foregoing considerations.

1.33“Committee” means the Joint Steering Committee, Joint Development Committee,
Joint Commercialization Committee or IP Committee, or any other subcommittee
established under Article 2, as applicable.

1.34“Compliance Audit” has the meaning set forth in Section 10.3(e).

1.35“Confidential Information” means, with respect to a Party, all Information
of such Party that is disclosed to the other Party under this Agreement, which
may include, without limitation, specifications, know-how, trade secrets,
technical information, models, business information, inventions, discoveries,
methods, procedures, formulae, protocols, techniques, data, and unpublished
patent applications, whether disclosed in oral, written, graphic, or electronic
form. All confidential Information disclosed by either Party pursuant to the
Existing Confidentiality Agreement shall be deemed to be Confidential
Information of the disclosing Party hereunder (with the mutual understanding and
agreement that any use or disclosure thereof that is authorized under Article 12
shall not be restricted by, or be deemed a violation of, such Existing
Confidentiality Agreement).

1.36“Control” means, with respect to any material, Information, or intellectual
property right, that a Party (a) owns such material, Information, or
intellectual property right, or (b) has a license or right to use to such
material, Information, or intellectual property right, in each case with the
ability to grant to the other Party access, a right to use, or a license, or a
sublicense (as applicable) to such material, Information, or intellectual
property right on the terms and conditions set forth herein, without violating
the terms of any agreement or other arrangement with any Third Party.

1.37“Core Indication” means any of the following: (a) treatment of anemia in
patients with chronic kidney disease undergoing dialysis, (b) treatment of
anemia in patients with chronic kidney disease not undergoing dialysis, (c) [ *
]).

1.38 “Covenant Period 1” has the meaning set forth in Section 7.4(a)(ii).

1.39“Covenant Period 2” has the meaning set forth in Section 7.4(a)(iii).

5.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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1.40“CPI-U” means the Consumer Price Index for All Urban Consumers (All Items),
or any successor to such published measure, not seasonally adjusted, as
published by the U.S. Department of Labor Bureau of Labor Statistics.

1.41“Designated Indication” has the meaning set forth in Section 3.5(a).

1.42“Designated Product” has the meaning set forth in Section 8.4(a).

1.43“Development” means all activities that relate to (a) obtaining, maintaining
or expanding Regulatory Approval of a Product for one or more indications or (b)
developing the process for the manufacture of clinical and commercial quantities
of drug substance or drug Product.  This includes: (i) preclinical testing,
toxicology and Clinical Trials; (ii) preparation, submission, review,
statistical analysis, report writing and development of data or information for
the purpose of submission to a governmental authority to obtain, maintain and/or
expand Regulatory Approval of a Product, and outside counsel regulatory legal
services related thereto; and (iii) manufacturing process development and
scale-up for drug substance and drug product,  test method development,
packaging development, stability testing, qualification and validation,
production of drug substance and drug product, in bulk for preclinical and
clinical studies, and related quality assurance technical support activities;
provided, however, that Development shall exclude Commercialization.  For
clarity, Development shall include those Phase 4 Clinical Trials that are
included in clause (b) of the definition of Phase 4 Clinical Trials.  “Develop”
has a correlative meaning.

1.44“Development Budget” means the budget associated with the activities
conducted under the Development Plan for the U.S., detailing the anticipated
Development Costs.

1.45“Development Costs” means all costs incurred by or on behalf of FibroGen or
AstraZeneca that are reasonably allocable to the Development of Products for the
U.S. in accordance with the Development Plan, which shall equal the sum of (a)
Personnel Costs, (b) the Fully Burdened Cost of Collaboration Compound or
Product or comparator drug, concomitant drug, placebo or other materials used in
any Clinical Trial or Nonclinical Studies, and (c) all other out-of-pocket
costs, in each case for activities for the U.S.

1.46“Development Data” has the meaning set forth in Section 3.10(a).

1.47“Development Plan” means the plan for conducting collaborative Development
of Products for approval and use in the U.S. and RoW, as set forth in Section
3.2(a).

1.48“Development Sharing Period” means the time period commencing on August 1,
2013 and ending on the date on which the Parties have incurred two hundred
thirty-three million Dollars ($233,000,000) in Development Costs.

1.49“Development Strategy” has the meaning set forth in Section 3.2(c).

6.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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1.50“DFCI Agreement” means the License Agreement between FibroGen and the
Dana-Farber Cancer Institute, Inc. (“DFCI”), dated March 29, 2006, a redacted
copy of which is attached hereto as Exhibit B.

1.51“Distributor” has the meaning set forth in Section 7.3(c).

1.52“Dollar” or “$” means United States dollar.

1.53“ESA Approved Indications” means the following indications: (a) treatment of
anemia in patients with chronic kidney disease undergoing dialysis, (b)
treatment of anemia in patients with chronic kidney disease not undergoing
dialysis, (c) [ * ].

1.54“EU” means all of the European Union member states as of the applicable time
during the Term.

1.55“Executive Officer” means, in the case of AstraZeneca, AstraZeneca’s Chief
Executive Officer or any senior executive designated by and who reports directly
to the Chief Executive Officer of AstraZeneca, and in the case of FibroGen,
FibroGen’s Chief Executive Officer.

1.56“Existing Confidentiality Agreement” means, collectively, the Non-Disclosure
Agreement between FibroGen and AstraZeneca dated June 21, 2012, as amended
February 7, 2013, and May 23, 2013, and the Non-Disclosure Agreement between
FibroGen and AstraZeneca dated April 1, 2013.

1.57“FCPA” means the U.S. Foreign Corrupt Practices Act of 1977, as amended,
including the rules and regulations thereunder.

1.58“FDA” means the United States Food and Drug Administration or its successor.

1.59“FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as
amended.

1.60“FG-4592” means the molecule with the chemical structure set forth on
Exhibit C.

1.61“FibroGen IPO” means the initial public offering of its securities by
FibroGen in any of the U.S., United Kingdom, Spain, France, Italy, Germany,
Japan, China or Hong Kong.

1.62“FibroGen Know-How” means all Information Controlled as of the Effective
Date or thereafter during the Term by FibroGen and/or its Affiliate(s) and
reasonably necessary or useful for the development, manufacture, use,
importation or sale of Collaboration Compounds or Products in the Field;
including, without limitation, any such Information made or generated by or on
behalf of FibroGen or its Affiliate in the course of performing FibroGen’s
obligations or exercising FibroGen’s rights under this Agreement. The use of
“Affiliate” in this definition shall exclude any Third Party that becomes an
Affiliate due to such Third Party’s acquisition of FibroGen, except as provided
in Section 15.5.  FibroGen Know-How shall exclude (a) rights under

7.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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any FibroGen Patents and FibroGen’s interest in the Joint Patents and Joint
Inventions and (b) any Third Party Information that is not included pursuant to
Section 8.8(d).

1.63“FibroGen Patents” means (i) the Listed Patents and (ii) all other Patents
(excluding any Joint Patents) that are Controlled as of the Effective Date or
thereafter during the Term by FibroGen and/or its Affiliate(s) and that claim
the composition of matter, manufacture or use of one or more Collaboration
Compounds or Products in the Field or that would otherwise be infringed (or with
respect to patent applications, would be infringed if issued or granted with the
then-currently pending claims), absent a license, by the manufacture, use or
sale of any Collaboration Compound or Product in the Field.  The use of
“Affiliate” in this definition shall exclude any Third Party that becomes an
Affiliate due to such Third Party’s acquisition of FibroGen except as provided
in Section 15.5.  FibroGen Patents does not include Third Party Patents that are
not included pursuant to Section 8.8(d).

1.64“FibroGen Technology” means the FibroGen Patents, FibroGen Know-How, and
FibroGen’s interest in Joint Patents and Joint Inventions.

1.65“Field” means (a) the treatment of anemia in humans and non-human animals,
which means any treatment intended to increase hemoglobin levels or utilization
or to increase hematocrit, as measured by acceptable clinical parameters,
including unit volume concentrations of hemoglobin, red blood cell volume, or
red blood cell count, and (b) any Designated Indication added to the Field
pursuant to Section 3.5.  For the avoidance of doubt, the Core Indications, the
ESA Approved Indications as well as the indications listed on Exhibit D are all
included in clause (a) of the preceding sentence.

1.66“First Commercial Sale” means, with respect to a Product and country in the
Territory, the first arm’s length sale for monetary value by AstraZeneca, its
Affiliates or its Sublicensees to a Third Party intended for end use or
consumption by the general public (regardless of when actual consumption occurs)
of such Product in such country after Regulatory Approval (and any pricing or
reimbursement approvals, if reasonably necessary to commence regular commercial
sales) has been obtained in such country. For the avoidance of doubt, sales
prior to receipt of Regulatory Approvals necessary to commence regular
commercial sales, such as so-called “treatment IND sales”, “named patient sales”
or “compassionate use sales”, shall not be construed as a First Commercial Sale.

1.67“Fully Burdened Cost” means, with respect to a Product, all costs actually
incurred by FibroGen or its Affiliates attributable and fairly allocable to
produce, package and distribute the Product to AstraZeneca or its carrier [ * ])
for the acquisition or sale of such Product, which costs to produce and package
the Product will include the direct material and labor and indirect costs
(fairly allocated) that are incurred by FibroGen or its Affiliates associated
with the manufacture, filling, packaging, labeling, and preparation of product
for shipment and/or other preparation of such Product, as applicable, including
non-refundable and non-creditable Indirect Taxes, customs fees and customs
duties.  Fully Burdened Cost will be determined in accordance with U.S. GAAP and
will include the attributable and fairly allocable costs of facilities, labor,
purchasing, depreciation of equipment, materials, payments to Third Parties for
any necessary

8.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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contract work for the manufacture or testing of the Product, quality assurance,
quality control and other testing (including validation studies), storage (if
requested by AstraZeneca), shipping and costs for distribution, and a reasonable
allocation of general and administrative overhead for the manufacturing
operations attributable to Product distribution to AstraZeneca.  These costs
shall include capacity reservation charges paid to a Third Party, and the
proportion of fixed overhead allocated to total available capacity reasonably
reserved for the production of a Product, less the amount included in budgeted
cost of goods (budgeted capacity); provided, that FibroGen shall use good faith
efforts to utilize any such reserved but unused capacity.  By way of example, if
fifteen percent (15%) of the total site capacity is reasonably reserved for the
production of the Product and for the same period budgeted capacity is planned
for only ten percent (10%) of the site, the fixed overhead related to the
remaining five percent (5%) dedicated capacity shall be included in Fully
Burdened Cost as reserve capacity.  Costs for distribution consist of the labor,
materials and reasonably allocated overhead necessary to prepare and package the
final product for shipment to AstraZeneca.

1.68“GCP” means the current standards for clinical trials for pharmaceuticals,
as set forth in the U.S. Code of Federal Regulations, ICH guidelines and
applicable regulations, laws or rules as promulgated thereunder, as amended from
time to time, and such standards of good clinical practice as are required in
other countries than the U.S. in which a Product is intended to be sold to the
extent such standards are not less stringent than U.S. GCP.

1.69“Generic Product” means, with respect to a Product and a particular country,
any pharmaceutical product (a) that is sold in such country by a Third Party
that is not a Sublicensee or Distributor selling such product under
authorization from AstraZeneca or its Affiliates, (b) that contains the same
Collaboration Compound as the relevant Product and that is in the same dosage
form as such Product and for the same route of administration as such Product
and is approved by the Regulatory Authority for such country for an indication
for which such Product obtained Regulatory Approval in such country and (c) that
is approved in reliance on the prior approval of such Product as determined by
the applicable Regulatory Authority.

1.70“Governmental Authority” means any multi-national, federal, state, local,
municipal or other government authority of any nature (including any
governmental division, subdivision, department, agency, bureau, branch, office,
commission, council, court or other tribunal).

1.71“Government Official” means (i) any individual or entity employed by or
acting on behalf of a government, government-controlled agency or entity or
public international organization, (ii) any political party, party official or
candidate, (iii) any individual or entity that holds or performs the duties of
an appointment, office or position created by custom or convention or (iv) any
individual or entity that holds himself, herself or itself out to be the
authorized intermediary of any of the foregoing.

1.72“HICP” means, with respect to a country, the Harmonised Index of Consumer
Prices for such country published by Eurostat.

9.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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1.73“HIF Compound” means any compound that stabilizes hypoxia-inducible factor
(“HIF”) or that modulates HIF prolyl hydroxylase activity.

1.74“Hourly Rate” means, as of the Effective Date, $[ * ], which is the blended
hourly fully burdened rate for FibroGen’s employees and agents conducting
Development activities.  The Hourly Rate will be adjusted annually as of each
January 1 (commencing 2014) to reflect the percentage increase or decrease (as
the case may be) from the preceding year in the average consumer price,
calculated as the average of (i) the annual percentage change of US CPI-U and
(ii) the average of the annual percentage changes of HICP for the 5 major EU
countries (UK, France, Germany, Italy, and Spain) for such annual period, except
as otherwise mutually agreed by the Parties.  The Hourly Rate includes, without
limitation, the following general expense categories: salaries and wages
(including bonuses, moving expenses, and payroll taxes), benefits provided
(including health benefits, defined contribution, defined benefit plans,
vacations, etc.), direct employee costs (including recruitment costs, internal
and external training costs, computer charges, automobile leases, subscriptions
and reference materials, telephone, fax, cellular phone, and copy machines and
related costs), and allocation of other overhead costs (including rent,
insurance, and utilities).

1.75“IND” means (a) an Investigational New Drug Application as defined in the
FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b)
the equivalent application to the equivalent Regulatory Authority in any other
regulatory jurisdiction, the filing of which is necessary to initiate or conduct
clinical testing of a pharmaceutical product in humans in such jurisdiction.

1.76“Indirect Taxes” means VAT, sales taxes, consumption taxes and other similar
taxes required by law to be disclosed on the invoice.

1.77“Information” means any data, results and information of any type
whatsoever, in any tangible or intangible form, including, without limitation,
know-how, trade secrets, practices, techniques, methods, processes, inventions,
developments, specifications, formulations, formulae, compositions of matter of
any type or kind, software, algorithms, marketing reports, clinical and
non-clinical study reports, regulatory submission documents and summaries,
expertise, stability, technology, test data including pharmacological,
biological, chemical, biochemical, toxicological and clinical test data,
analytical and quality control data, stability data, studies and procedures, in
all cases, patentable or otherwise.

1.78“Initial Development Plan” has the meaning set forth in Section 3.2(b).

1.79“Inventions” has the meaning set forth in Section 9.2.

1.80“IP Committee” has the meaning set forth in Section 9.1.

1.81“Joint Commercialization Committee” or “JCC” means the committee formed by
the Parties as described in Section 2.4.

10.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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1.82“Joint Development Committee” or “JDC” means the committee formed by the
Parties as described in Section 2.3.

1.83“Joint Inventions” has the meaning set forth in Section 9.2.

1.84“Joint Patents” has the meaning set forth in Section 9.2.

1.85“Joint Project Team” or “JPT” has the meaning set forth in Section 2.9.

1.86“Joint Steering Committee” or “JSC” means the committee formed by the
Parties as described in Section 2.2.

1.87“Large Dialysis Organization” or “LDO” means (a) an organization that
operates out-patient dialysis centers and that has at least twenty-five percent
(25%) of the market share (measured by number of patients as determined by USRDS
or any successor) of dialysis centers in the U.S. and (b) Dialysis Clinic
Inc.  Examples of Large Dialysis Organizations as of the Effective Date in
clause (a) are Fresenius Medical Care and DaVita HealthCare Partners Inc.

1.88“Listed Patents” means the Patents listed on Exhibit E.  The Parties may
update such exhibit from time to time upon mutual written agreement, e.g., to
update the status of the listed Patents, to add newly filed FibroGen Patents, or
to make other agreed revisions.

1.89“Marketing Authorization Application” or “MAA” means an application for
Regulatory Approval in a country, territory or possession other than the U.S.

1.90“Marks” has the meaning set forth in Section 9.11.

1.91“Material Anti-Corruption Law Violation” means a violation of an
Anti-Corruption Law relating to the subject matter of this Agreement which [ * ]
a material adverse effect on either Party or on the reputation of either Party
because of its relationship with the other Party.

1.92“Medical Scientific Liaison” or “MSL” means a field-based professional with
scientific, medical and clinical expertise who provides medical and scientific
support for marketed products, new indications and compounds in development or
registration.  An MSL engages in scientific exchange with medical and scientific
experts including investigators, key opinion leaders, physicians and other
medical professionals and customers.

1.93“NDA” means a New Drug Application, as defined in the FD&C Act and
applicable regulations promulgated thereunder by the FDA.

11.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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1.94“Net Sales” means the gross invoiced amount on sales of a Product by
AstraZeneca, its Affiliates or its or their Sublicensees to Third Parties
(including Distributors but excluding Sublicensees) in the Territory, after
deduction of the following amounts:

(a)normal and customary trade, quantity or prompt settlement discounts
(including chargebacks and allowances) actually allowed;

(b)amounts repaid or credited by reason of rejection, returns or recalls of
goods, rebates or bona fide price reductions determined by AstraZeneca, its
Affiliates or its or their Sublicensees in good faith;

(c)rebates and similar payments made with respect to sales paid for by managed
care organizations, hospitals, other buying groups or any governmental or
regulatory authority such as, by way of illustration and not in limitation of
the Parties’ rights under this Agreement, federal or state Medicaid, Medicare or
similar state program in the U.S. or equivalent governmental program in any
other country;

(d)any invoiced amounts that are not collected by AstraZeneca, its Affiliates or
its or their Sublicensees, including bad debts (provided that such amounts will
be added to Net Sales if and when recovered), up to an amount not to exceed [ *
]) of Net Sales;

(e)excise taxes, Indirect Taxes, customs duties, customs levies and import fees
imposed on the sale, importation, use or distribution of the Products;

(f)[ * ]; and

(g)as an allowance for transportation costs, distribution expenses, special
packaging and related insurance charges, [ * ].

For clarity, any deduction made pursuant to one subsection above, shall not be
additionally deducted in the event that such deduction may also apply in a
separate subsection (i.e., no double-counting).

In the event that a Product is sold in any country in the form of a Combination
Product, Net Sales of such Combination Product shall be adjusted by multiplying
actual Net Sales of such Combination Product in such country calculated pursuant
to the foregoing definition of “Net Sales” by the fraction A/(A+B), where A is
the average invoice price in such country of any Product that contains the same
Collaboration Compound(s) as such Combination Product as its sole active
ingredient(s), if sold separately in such country, and B is the average invoice
price in such country of each product that contains active ingredient(s) other
than the Collaboration Compound(s) contained in such Combination Product as its
sole active ingredient(s), if sold separately in such country; provided that the
invoice price in a country for each Product that contains only the Collaboration
Compound(s) and each product that contains solely active ingredient(s) other
than the Collaboration Compound(s) included in the Combination Product shall be
for a quantity comparable to that used in such Combination Product and of
substantially the same class, purity and potency or functionality, as
applicable.  If either such Product that contains the Collaboration

12.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Compound(s) as its sole active ingredient or a product that contains the active
ingredient(s) (other than the Product) in the Combination Product as its sole
active ingredient(s) is not sold separately in a particular country, the Parties
shall negotiate in good faith a reasonable adjustment to Net Sales in such
country that takes into account the medical contribution to the Combination
Product of and all other factors, including patent coverage, reasonably relevant
to the relative value of the Collaboration Compound(s) on the one hand and all
of the other active ingredient(s), collectively, on the other hand.

In the case of pharmacy incentive programs, hospital performance incentive
programs, chargebacks, disease management programs, similar programs or
discounts on portfolio product offerings, all rebates, discounts and other forms
of reimbursements shall be allocated among products on the basis on which such
rebates, discounts and other forms of reimbursements were actually granted or,
if such basis cannot be determined, in accordance with AstraZeneca’s, its
Affiliates’ or its or their Sublicensees’ existing allocation method; provided
that any such allocation shall be done in accordance with applicable law,
including any price reporting laws, rules and regulations.

Net Sales will be calculated using AstraZeneca’s internal audited systems
consistently applied to report such sales as adjusted for any of the deductions
set forth above not taken into account in such systems.  Deductions pursuant to
item (d) above will be taken in the Calendar Quarter in which such sales are no
longer recorded as a receivable.

Any free of charge disposition or use of reasonable quantities of a Product, up
to the amount determined by the JCC, for regulatory or marketing purposes (it
being understood and agreed that neither Party shall have the right to
distribute the Product as samples except pursuant to Section 5.7) such as
compassionate use or indigent patient programs, will not be deemed a sale or
disposition for calculating Net Sales.  Sales and other transfer of Product
between any of AstraZeneca, its Affiliates and Sublicensees will not give rise
to Net Sales except if the purchaser is an end user.

1.95“Nonclinical Studies” means all in vivo and in vitro non-human studies of
Collaboration Compounds and Products, including non-clinical pharmacology,
toxicology, tumor and teratogenicity studies.

1.96“Patent” means (i) all national, regional and international patents and
patent applications, including provisional patent applications, (ii) all patent
applications filed either from such patents, patent applications or provisional
applications or from an application claiming priority from any of these,
including divisionals, continuations, continuations-in-part, provisionals,
converted provisionals, and continued prosecution applications, (iii) any and
all patents that have issued or in the future issue from the foregoing patent
applications ((i) and (ii)), including utility models, petty patents and design
patents and certificates of invention, (iv) any and all extensions or
restorations by existing or future extension or restoration mechanisms,
including revalidations, reissues, re-examinations and extensions (including any
supplementary protection certificates and the like) of the foregoing patents or
patent applications ((i), (ii) and (iii)), and (v) any similar rights, including
so-called pipeline protection, or any importation, revalidation, confirmation or

13.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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introduction patent or registration patent or patent of additions to any such
foregoing patent applications and patents.

1.97“Personnel Costs” means, with respect to a reporting period, the total
number of hours FibroGen employees and consultants or AstraZeneca employees and
consultants, as applicable, actually spent in such reporting period conducting
activities under the Development Plan multiplied by the Hourly Rate.  Such
activities may include, without limitation, clinical development, research
activities directly in support of the Development program, management of
clinical research organizations and other vendors, regulatory, supply chain,
medical monitoring, biostatistics, safety data collection, monitoring and
exchange, and clinical and nonclinical finance and contracting.

1.98“Pharmacovigilance Agreement” has the meaning set forth in Section 4.3.

1.99“Phase 2 Clinical Trial” means a Clinical Trial of a Product that would
satisfy the requirements of 21 CFR 312.21(b) or its foreign equivalents.

1.100“Phase 3 Clinical Trial” means a Clinical Trial of a Product that would
satisfy the requirements of 21 CFR 312.21(c) or its foreign equivalents.

1.101“Phase 4 Clinical Trial” means a Clinical Trial of a Product conducted
after Regulatory Approval of such Product has been obtained from an appropriate
Regulatory Authority, which trial is (a) conducted voluntarily by a Party to
enhance marketing or scientific knowledge of the Product, or (b) conducted due
to a request or requirement of a Regulatory Authority.

1.102“Product” means any pharmaceutical product (including all forms,
presentations, dosage strengths and formulations) containing as an active
ingredient a Collaboration Compound alone or in combination with one or more
other therapeutically active ingredients.

1.103“Product Information” has the meaning set forth in Section 12.1.

1.104“Product Infringement” has the meaning set forth in Section 9.5(a)(i).

1.105“Promotional Materials” means all sales representative training materials
and all written, printed, graphic, electronic, audio or video matter, including,
without limitation, journal advertisements, sales visual aids, formulary
binders, reprints, direct mail, direct-to-consumer advertising, internet
postings and sites and broadcast advertisements intended for use or used by
either Party or its Affiliates or sublicensees in connection with any promotion
of a Product.

1.106“Publication” has the meaning set forth in Section 12.5(b).

1.107“Regulatory Approval” means all approvals necessary for the manufacture,
marketing, importation and sale of a Product for one or more indications in the
Field and in a country or regulatory jurisdiction, which may include, without
limitation, satisfaction of all applicable regulatory and notification
requirements, but which shall exclude any pricing and reimbursement approvals.

14.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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1.108“Regulatory Authority” means, in a particular country or regulatory
jurisdiction, any applicable Governmental Authority involved in granting
Regulatory Approval and/or, to the extent required in such country or regulatory
jurisdiction, pricing or reimbursement approval of a Product in such country or
regulatory jurisdiction.

1.109“Regulatory Materials” means regulatory applications, submissions,
notifications, registrations, Regulatory Approvals and/or other material filings
or correspondence submitted to or received from Regulatory Authorities
(including minutes and official contact reports relating to any communications
with any Regulatory Authority), or other approvals granted by, a Regulatory
Authority that are necessary or reasonably desirable in order to Develop,
manufacture, market, sell or otherwise Commercialize a Product in a particular
country or regulatory jurisdiction.  Regulatory Materials include, without
limitation, INDs, MAAs, and NDAs.

1.110“Representatives” has the meaning set forth in Section 10.3(a).

1.111“RoW” means all countries of the Territory other than the U.S. For clarity,
except as expressly set forth in Article 2, the territories licensed under the
China Agreement are not included in RoW.

1.112“SEC” means the U.S. Securities and Exchange Commission.

1.113“Sublicense Agreement” has the meaning set forth in Section 7.3(b).

1.114“Sublicensee” means any Third Party granted a sublicense by AstraZeneca or
any of its Affiliates under the rights licensed to AstraZeneca pursuant to
Article 7.

1.115“Subsequent Agreement” has the meaning set forth in Section 7.4(c).

1.116“Subsequent Licensee” has the meaning set forth in Section 7.4(c).

1.117“Supply and Quality Agreement” has the meaning set forth in Section 6.5.

1.118“Tax and Taxation” means any form of tax or taxation, levy, duty, charge,
social security charge, contribution, or withholding of whatever nature
(including any related fine, penalty, surcharge or interest) imposed by, or
payable to, a Tax Authority.

1.119“Tax Authority” or “Tax Authorities” means any government, state or
municipality, or any local, state, federal or other fiscal, revenue, customs, or
excise authority, body or official anywhere in the world, authorized to levy
Tax.

1.120“Technical Product Failure” means (a) a [ * ] of a Collaboration Compound
or Product under Development or Commercialization under this Agreement, as
determined (including following a review of the Carcinogenicity Studies) (i) by
a consensus decision by the JSC or (ii), following referral of the matter to the
Executive Officers pursuant to Section 2.6(c), by a consensus decision by the
Executive Officers, or (iii), in the event that a consensus decision by the
Executive Officers has not been attained within twenty (20) Business Days after
the JSC’s

15.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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submission of the matter to them, by expedited resolution in accordance with
Section 14.8; or (b) a Regulatory Authority action or decision [ * ].

1.121“Term” has the meaning set forth in Section 13.1.

1.122“Territory” means all countries of the world other than (a) the countries
listed on Exhibit A and (b) China (including Hong Kong SAR and Macau SAR, but
excluding Taiwan region).  The Territory consists of the U.S. and RoW.

1.123“Third Party” means any entity other than FibroGen or AstraZeneca or an
Affiliate of either of them.

1.124“Transatlantic Clinical Development Plan” or “TCDP” has the meaning set
forth in Section 3.2(b).

1.125“U.S.” means the United States of America (including all possessions and
territories thereof).

1.126“U.S. Commercialization Budget” has the meaning set forth in Section 5.2.

1.127“U.S. Commercialization Plan” has the meaning set forth in Section 5.2.

1.128“U.S. GAAP” means generally accepted accounting principles in the U.S.

1.129“Valid Claim” means, with respect to a Product in a particular country, any
claim of a FibroGen Patent that specifically or generically claims (i) the
Collaboration Compound included in such Product as a composition of matter, (ii)
a method of manufacture of such Collaboration Compound, or (iii) a method of
treatment or other use of such Collaboration Compound [ * ] and either:

(a)with respect to a granted and unexpired Patent in such country, that (i) has
not been held permanently revoked, unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction, which decision is
unappealable or unappealed within the time allowed for appeal, and (ii) has not
been abandoned, disclaimed, denied or admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise; or

(b)with respect to a pending Patent application, that was filed and is being
prosecuted in good faith and has not been abandoned or finally disallowed
without the possibility of appeal or re-filing of the application. For purposes
hereof, a claim in a patent application that has not been granted within [ * ])
years from the priority date for such claim (or, with respect to [ * ]) shall
not be considered to be a Valid Claim, unless and until such claim thereafter
issues such that it is included in subsection (a) above.

16.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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ARTICLE 2

Collaboration; Governance

2.1Collaboration Overview.  The Parties desire and intend to collaborate with
respect to the Development and Commercialization of Products in the Field in the
Territory, as and to the extent set forth in this Agreement (the
“Collaboration”).  It is intended that the Collaboration utilize AstraZeneca’s
position as a large, fully-integrated pharmaceutical company, while recognizing
FibroGen’s current experience and expertise in, and aspirations to further
develop its clinical development and commercialization capabilities with respect
to, HIF Compounds.

2.2Joint Steering Committee.

(a)Purpose; Formation.  The Parties hereby establish a joint steering committee
(the “JSC”) that will monitor and oversee their activities under this Agreement
in the Territory and under the China Agreement in China, resolve disputes within
subcommittees and facilitate communications between the Parties with respect to
the Development and Commercialization of Products in the Territory and in China
(under the China Agreement), all in accordance with this Section 2.2.

(b)Composition.  Each Party shall initially appoint five (5) representatives of
such Party or its applicable Affiliates to the JSC. Each representative
appointed to the JSC shall have sufficient seniority within the applicable Party
or its Affiliate to make decisions arising within the scope of the JSC’s
responsibilities.  The Parties’ initial representatives to the JSC are set forth
on Exhibit G.  The JSC may change its size from time to time by mutual consent
of its members, provided that the JSC shall at all times consist of an equal
number of representatives of each of FibroGen and AstraZeneca.  Each Party may
replace its JSC representatives at any time upon written notice to the other
Party.  The JSC may invite non-members (including consultants and advisors of a
Party who are under an obligation of confidentiality consistent with this
Agreement) to participate in the discussions and meetings of the JSC, provided
that such participants shall have no voting authority at the JSC.  Each Party
shall appoint a secretariat to the JSC who is not a member of the JSC.

(c)Specific Responsibilities.  In addition to its overall responsibility for
monitoring and providing a forum to discuss and coordinate the Parties’
activities under this Agreement, the JSC shall in particular:

(i)oversee the collaborative activities of the Parties under this Agreement and
the China Agreement, including overseeing the China Committee;

(ii)oversee and delegate responsibility for the use of any information arising
under the Astellas Agreements, to the extent that (A) [ * ] such information;
and (B) such information [ * ] this Agreement;

(iii)review and fully discuss the Development and Commercialization of Products
and any other ongoing activities;

17.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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(iv)receive and discuss reports from the JDC and JCC and provide guidance
thereto, and approve the Development Plan (and associated Development Budget)
and U.S. Commercialization Plan and amendments thereto;

(v)receive and discuss reports from the China Committee and provide guidance
thereto, and approve the applicable Development and Commercialization plans and
budgets;

(vi)receive and discuss reports from the IP Committee, provide guidance thereto
and review strategies for obtaining, maintaining, defending and enforcing patent
and trademark protection for Products within the Territory;

(vii)attempt to resolve issues presented to it by, and disputes within, the JDC,
JCC and China Committee or any other subcommittee;

(viii)at least annually, discuss and determine indications for Development of
Products;

(ix)review and approve the filing of an NDA for a Product in the U.S. prior to
submission;

(x)establish such additional joint subcommittees as it deems necessary to
achieve the objectives and intent of this Agreement;

(xi)review and approve the JPT Charter and any subsequent amendments thereto,
including the composition and responsibilities of the Core JPT; and

(xii)perform such other functions as appropriate to further the purposes of this
Agreement as allocated to it in writing by the Parties.

The JSC shall further – until the date when the JDC or the JCC has been formed –
assume the responsibilities of the JDC and the JCC, as applicable, and delegate
certain responsibilities to the Core JPT as set forth in Schedule G(a) for the
JDC and Schedule G(b) for the JCC.

(d)Delegation or Assumption of Responsibilities by the JSC.  The JSC may by
mutual consent of its members:

(i)delegate any of its responsibilities set out in this Section 2.2 or in
Schedule G(a) or G(b) to any of its subcommittees or the Core JPT; or

(ii)assume any responsibilities assigned to any of its subcommittees.

(e)Meetings.  The JSC shall hold its first meeting within thirty (30) days after
the Effective Date.  The JSC shall meet at least one (1) time per Calendar
Quarter during the Term unless the Parties mutually agree in writing to a
different frequency for such meetings.  Either

18.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Party may also call a special meeting of the JSC (by videoconference or
teleconference) by at least ten (10) Business Days prior written notice to the
other Party in the event such Party reasonably believes that a significant
matter must be addressed prior to the next scheduled meeting, and such Party
shall provide the JSC no later than ten (10) Business Days prior to the special
meeting with materials reasonably adequate to enable an informed decision;
provided, however, that where a special meeting is called for on shorter notice
with regard to a matter that does not admit delay, such notice and such
materials shall be provided as early as possible in advance of such meeting.  No
later than ten (10) Business Days (or such shorter period as may be necessary in
the event of a special meeting called for on shorter notice in accordance with
the foregoing) prior to any meeting of the JSC, the secretariats of the JSC
shall jointly prepare and circulate an agenda for such meeting.  The JSC may
meet in person, by videoconference or by teleconference.  Notwithstanding the
foregoing, at least two (2) meetings per Calendar Year shall be in person unless
the Parties mutually agree in writing to waive such requirement in lieu of a
videoconference or teleconference.  In-person JSC meetings will be held at
locations alternately selected and hosted by FibroGen and by AstraZeneca.  The
host Party shall be responsible for the costs and expenses of the JSC meeting
hosted, provided that each Party will bear the expense of its respective JSC
members’ and other attendees’ participation in JSC meetings, including travel
costs.  Meetings of the JSC shall be effective only if at least one (1)
representative of each Party is present or participating in such meeting.  The
JSC secretariat of the host Party will be responsible for keeping reasonably
detailed written minutes of all JSC meetings that reflect, without limitation,
material decisions made at such meetings.  The JSC secretariat of the host Party
shall send draft meeting minutes to the other Party’s JSC secretariat, and each
secretariat shall seek and obtain review and approval of such minutes from its
respective Party’s members of the JSC within ten (10) Business Days after each
JSC meeting.  Such minutes will be deemed approved unless one or more members of
the JSC objects to the accuracy of such minutes within ten (10) Business Days of
receipt.

(f)Decision-Making.  In addition to resolving issues specifically delegated to
it, the JSC shall have the authority to resolve any disputes within the
Collaboration not resolved by the JDC, JCC, China Committee and any other
committees that the Parties may subsequently create to assist in governance of
the Collaboration, except where expressly specified elsewhere in this
Agreement.  The representatives from each Party will have, collectively, one (1)
vote on behalf of that Party, and all decision making shall be by
consensus.  Disputes at the JSC shall be handled in accordance with Section 2.6.

2.3Joint Development Committee.

(a)Formation; Composition.  At a time determined by the JSC, the Parties shall
establish a committee to oversee Development of Product(s) in the Territory and
in China in accordance with the Development Plan(s) for such Product(s) and to
coordinate the Development activities of the Parties (the “JDC”) and prior
thereto, the JSC will be responsible for all JDC responsibilities except for the
specific responsibilities it delegates to the Core JPT as set out in Schedule
G(a).  

Each Party shall appoint three (3) representatives of such Party or its
Affiliates to the JDC at its inception. Each representative appointed to the JDC
shall have knowledge and expertise in relevant

19.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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aspects of the development of small molecule pharmaceutical products, including
in the area of chronic kidney disease or cardiovascular or metabolic disorders
and having sufficient seniority within the applicable Party or Affiliate to make
decisions arising within the scope of the JDC’s responsibilities.  The JDC may
change its size from time to time by mutual consent of its members, provided
that the JDC shall consist at all times of an equal number of representatives of
each of FibroGen and AstraZeneca.  Each Party may replace its JDC
representatives at any time upon written notice to the other Party.  The JDC may
invite non-members (including consultants and advisors of a Party who are under
an obligation of confidentiality consistent with this Agreement) to participate
in the discussions and meetings of the JDC, provided that such participants
shall have no voting authority at the JDC.  The JDC shall have two (2)
co-chairmen, one selected by FibroGen and one selected by AstraZeneca.  The role
of the co-chairmen shall be to convene and preside at meetings of the JDC, but
they shall have no additional powers or rights beyond those held by the other
JDC representatives.  Each Party shall appoint a secretariat to the JDC.

(b)Specific Responsibilities of the JDC.  In addition to its general
responsibilities, the JDC (or the JSC until the JDC is formed, with certain
delegations as set forth in this Section 2.3 and Schedule G(a)) shall in
particular:

(i)provide regular reports to the JSC regarding the development of the Product,
and discuss, prepare and submit to the JSC for approval annual and interim
amendments to the Development Plan (and the Development Budget) for each
Product;

(ii)discuss and manage the implementation of the Initial Development Plan;

(iii)oversee the conduct of Development;

(iv)discuss the audited final report from the Carcinogenicity Studies, including
whether or not a Technical Product Failure has occurred, and provide input
thereon to the JSC;

(v)propose to the JSC particular studies to be conducted;

(vi)create, implement and review the Development Strategy for Development in the
Territory and the design of all Clinical Trials and Nonclinical Studies
conducted under each Development Plan, including Phase 4 Clinical Trials;

(vii)oversee any CMC related development activities, e.g. stability studies or
packaging development, as well as other activities to prepare for supply of drug
substance and finished Product for Commercialization, including to oversee the
selection process for, and select (pursuant to Section 6.4), a contract
manufacturer to be used by FibroGen for commercial supplies;

(viii)decide whether and when to initiate or discontinue any Clinical Trial and
any Nonclinical Study under each Development Plan, including Phase 4 Clinical
Trials;

20.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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(ix)allocate budgeted resources and determine priorities for each Clinical Trial
and Nonclinical Study under each Development Plan, including Phase 4 Clinical
Trials;

(x)oversee the conduct of all Clinical Trials and Nonclinical Studies under each
Development Plan, including Phase 4 Clinical Trials;

(xi)select Third Party contractors to conduct Clinical Trials of Products;

(xii)facilitate the flow of Information between the Parties with respect to the
Development of Products, including Development Data [ * ] under this Agreement;

(xiii)discuss whether to Develop Products for other indications and propose any
such indications to the JSC;

(xiv)allocate primary responsibility as between the Parties for tasks relating
to Development of Products where not already specified in the Development Plan;

(xv)discuss the requirements for Regulatory Approval in the Territory and
oversee and coordinate regulatory matters with respect to Products in the
Territory, including to review and approve material regulatory filings (other
than the filing of an NDA in the U.S., which shall be approved by the JSC) prior
to submission thereof;

(xvi)establish a publication strategy for publications and presentations related
to Products in the Territory and review and approve all such publications in
accordance with Section 12.5;

(xvii)facilitate the flow of Information between the Parties with respect to
obtaining Regulatory Approval for Products; and

(xviii)perform such other functions as may be appropriate to further the
purposes of this Agreement, as directed by the JSC.

(c)Meetings.  Following its inception,  the JDC shall meet at least one (1) time
per Calendar Quarter (or more frequently when necessary), spaced at regular
intervals, unless the Parties mutually agree in writing to a different
frequency.  Either Party may also call a special meeting of the JDC (by
videoconference or teleconference) by at least ten (10) Business Days prior
written notice to the other Party in the event such Party reasonably believes
that a significant matter must be addressed prior to the next scheduled meeting,
and such Party shall provide the JDC no later than ten (10) Business Days prior
to the special meeting with materials reasonably adequate to enable an informed
decision; provided, however, that where a special meeting is called for on
shorter notice with regard to a matter that does not admit delay, such notice
and such materials shall be provided as early as possible in advance of such
meeting.  No later than ten (10) Business Days (or such shorter period as may be
necessary in the event of a special meeting called for on shorter notice in
accordance with the foregoing) prior to any meeting of the JDC, the secretariats
shall jointly prepare and circulate an agenda for such meeting; provided,
however, that either Party shall be free to propose additional topics to be
included on such agenda, either prior to or, subject

21.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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to the consent of the other Party, in the course of such meeting.  The JDC may
meet in person, or at the request of either Party, by videoconference or
teleconference.  In-person JDC meetings will be held at locations alternately
selected and hosted by FibroGen and by AstraZeneca.  Each Party shall report to
the JDC on all material issues relating to the Development of Products for and
in the Territory at the JDC meeting occurring after such issues arise.  The host
Party shall be responsible for the costs and expenses of the JDC meeting hosted,
provided that each Party will bear the expense of its respective JDC members’
and other attendees’ participation in JDC meetings, including travel
costs.  Meetings of the JDC shall be effective only if at least one (1)
representative of each Party is present or participating in such meeting.  The
secretariat of the host Party shall be responsible for keeping reasonably
detailed written minutes of all JDC meetings that reflect all decisions made at
such meetings.  The secretariat of the host Party shall send meeting minutes to
the other Party’s secretariat, and each secretariat shall seek and obtain review
and approval of such minutes from its respective Party’s members of the JDC
within ten (10) Business Days after each JDC meeting.  Minutes will be deemed
approved unless one or more members of the JDC objects to the accuracy of such
minutes within ten (10) Business Days of receipt.

(d)Decision-Making.  The JDC shall act by consensus.  The representatives from
each Party will have, collectively, one (1) vote on behalf of that Party.  If
the JDC cannot reach consensus on an issue that comes before the JDC and over
which the JDC has oversight, then the Parties shall refer such matter to the JSC
for resolution in accordance with Sections 2.2(e) and 2.6(b).

2.4Joint Commercialization Committee.

(a)Formation; Composition.  At a time determined by the JSC, but no later than
the earlier of (i) eighteen (18) months prior to the date of the expected First
Commercial Sale of the Product in the U.S. and (ii) six (6) months prior to the
projected date of submission of the first NDA for the Product in the U.S., the
Parties shall establish a committee to oversee Commercialization of Products in
the Territory and in China (the “JCC”), and prior thereto, the JSC will be
responsible for all JCC responsibilities except for the specific
responsibilities it delegates to the Core JPT as set out in Schedule G(b).  

Each Party shall appoint three (3) representatives of such Party or its
Affiliate to the JCC at its inception. Each representative appointed to the JCC
shall have knowledge and expertise in relevant aspects of the commercialization
of small molecule pharmaceutical products, including in the area of chronic
kidney disease or cardiovascular or metabolic disorders and having sufficient
seniority within the applicable Party or its Affiliate to make decisions arising
with the scope of the JCC’s responsibilities.  The JCC may change its size from
time to time by mutual consent of its members, provided that the JCC shall
consist at all times of an equal number of representatives of each of FibroGen
and AstraZeneca.  Each Party may replace its JCC representatives at any time
upon written notice to the other Party.  The JCC may invite non-members
(including consultants and advisors of a Party who are under an obligation of
confidentiality consistent with this Agreement) to participate in the
discussions and meetings of the JCC, provided that such participants shall have
no voting authority at the JCC.  The JCC shall have a chairman, who shall be
selected by AstraZeneca.  The role of the chairman shall be to convene and
preside at meetings of the JCC,

22.

 

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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but the chairman shall have no additional powers or rights beyond those held by
the other JCC representatives.

(b)Specific Responsibilities of the Joint Commercialization Committee.  In
addition to its general responsibilities, the Joint Commercialization Committee
(or the JSC until the JCC is formed, with certain delegations as set forth in
this Section 2.4 and Schedule G(b)) shall in particular:

(i)oversee Commercialization in the Territory and (as set out in more detail in
the China Agreement) China;

(ii)regularly report to the JSC regarding the Commercialization of the Products,
and discuss, prepare and submit for approval to the JSC the U.S.
Commercialization Plan for each Product in the U.S., including any amendments
thereto;

(iii)review and approve each commercialization plan for the RoW prepared by
AstraZeneca;

(iv)oversee implementation of each U.S. Commercialization Plan;

(v)coordinate the Commercialization activities of FibroGen and AstraZeneca with
respect to Products, including pre-launch and post-launch activities;

(vi)allocate primary responsibility as between the Parties for tasks relating to
Commercialization of Products in the U.S.;

(vii)determine the amount of Product to be distributed free of charge annually
for regulatory or marketing purposes or investigator-initiated trials (it being
understood and agreed that neither Party shall have the right to distribute the
Product as samples except pursuant to Section 5.7);

(viii)oversee global harmonization of the Product;

(ix)be responsible for publication matters as described in Section 2.3(b)(xvi)
upon transition of such responsibility from the JDC to the JCC; and

(x)perform such other functions as appropriate to further the purposes of this
Agreement, as directed by the JSC.

(c)Meetings.  Following its inception, the JCC shall meet at least one (1) time
per Calendar Quarter, spaced at regular intervals unless the Parties mutually
agree in writing to a different frequency.  Either Party may also call a special
meeting of the JCC (by videoconference or teleconference) by at least ten (10)
Business Days prior written notice to the other Party in the event such Party
reasonably believes that a significant matter must be addressed prior to the
next scheduled meeting, and such Party shall provide the JCC no later than ten
(10) Business Days prior to the special meeting with materials reasonably
adequate to enable an informed decision; provided, however, that where a special
meeting is called for on shorter notice with regard to a matter that does not
admit delay, such notice and such materials shall be provided as early as

23.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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possible in advance of such meeting.  No later than ten (10) Business Days (or
such shorter period as may be necessary in the event of a special meeting called
for on shorter notice in accordance with the foregoing) prior to any meeting of
the JCC, the secretariats shall jointly prepare and circulate an agenda for such
meeting; provided, however, that either Party shall be free to propose
additional topics to be included on such agenda, either prior to or, subject to
the consent of the other Party, in the course of such meeting.  The JCC may meet
in person, by videoconference, or by teleconference.  In-person JCC meetings
will be held at locations alternately selected and hosted by FibroGen and by
AstraZeneca.  Meetings of the JCC shall be effective only if at least one (1)
representative of each Party is present or participating in such meeting.  Each
Party shall report to the JCC on all material issues relating to the
Commercialization of Products promptly after such issues arise.  The host Party
shall be responsible for the costs and expenses of the JCC meeting hosted,
provided that each Party will bear the expense of its respective JCC members’
and other attendees’ participation in JCC meetings, including travel costs.  The
secretariat of the host Party will be responsible for preparing reasonably
detailed written minutes of JCC meetings that reflect all decisions made at such
meetings.  The secretariat of the host Party shall send meeting minutes to the
other Party’s secretariat, and each secretariat shall seek and obtain review and
approval of such minutes from its respective Party’s members of the JCC within
ten (10) Business Days after each JCC meeting.  Minutes will be deemed approved
unless one or more members of the JCC objects to the accuracy of such minutes
within ten (10) Business Days of receipt.

(d)Decision-Making. The JCC shall act by consensus.  The representatives from
each Party will have, collectively, one (1) vote on behalf of that Party.  If
the JCC cannot reach consensus on an issue that comes before the JCC and over
which the JCC has oversight, then the Parties shall refer such matter to the JSC
for resolution  in accordance with Sections 2.2(e) and 2.6.

2.5Coordination with Astellas.  FibroGen shall designate one of AstraZeneca’s
JSC representatives (as selected by AstraZeneca) to serve as a member of the
steering committee under the Astellas Collaboration, who (except as described in
the next sentence) shall be entitled to participate in the decision-making of
such committee pursuant to the Astellas EU Agreement.  The designated
representative will be permitted to attend meetings of such committee; provided
that such representative shall not have the right to attend portions of (or
participate in decision-making with respect to) any such meeting that are not
relevant to the Development or Commercialization of Products in the Territory or
in China.

2.6Resolution of Committee Disputes.

(a)Within Operating Committees.  All decisions within any Committee other than
the JSC shall be made by consensus, and if a dispute arises which cannot be
resolved within such Committee, then the representatives of either Party may
cause such matter to be referred to the JSC for resolution as provided in
Section 2.2(e).

(b)Within The JSC. All decisions within the JSC (whether originating there, or
referred to it by an operating Committee) shall be made by consensus.  If a
matter is referred by an operating Committee to the JSC, it shall use good faith
efforts, in compliance with Section 2.6(d), to resolve promptly such matter.  If
the JSC is unable to reach consensus on any issue for which it is responsible,
within ten (10) Business Days after a Party affirmatively states that a

24.

 

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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decision needs to be made, either Party may elect to submit such issue to the
Parties’ Executive Officers in accordance with Section 2.6(c).

(c)Referral to Executive Officers.  If a Party makes an election under Section
2.6(b) to refer a matter to the Executive Officers, the JSC shall submit in
writing the respective positions of the Parties to their respective Executive
Officers.  Such Executive Officers shall use good faith efforts, in compliance
with Section 2.6(d), to resolve promptly such matter, which good faith efforts
shall include at least one meeting (in-person, by telephone, video conference or
other appropriate means) between such Executive Officers within twenty (20)
Business Days after the JSC’s submission of such matter to them.  If the
Executive Officers are unable to reach consensus on any such matter within such
twenty (20) Business Day period, then either Party may invoke the dispute
resolution provisions of Article 14; provided, however, that:

(i)FibroGen’s Executive Officer shall have the final say with respect to:   [ *
]

(1)[ * ];

(ii)AstraZeneca’s Executive Officer shall have the final say with respect to:

(1)[ * ].

(d)Good Faith.  In conducting themselves on Committees, and in exercising their
rights under this Section 2.6, all representatives of both Parties shall
consider diligently, reasonably and in good faith all input received from the
other Party, and shall use reasonable efforts to reach consensus on all matters
before them.  In exercising any decision making authority granted to it under
this Article 2, each Party shall act based on its good faith judgment of what is
in the best interests of the Products and the Collaboration.

2.7Alliance Managers.  Each Party shall, within thirty (30) days following the
Effective Date, appoint a single person who shall oversee contact between the
Parties for all subject matter related to the Collaboration between meetings of
the JSC, JPT, JDC and JCC, and shall have such other responsibilities as the
Parties may agree in writing after the Effective Date (such person, the
“Alliance Manager”). Each Party may replace its Alliance Manager at any time by
notice in writing to the other Party.  The Alliance Managers shall work together
to manage and facilitate the Collaboration governance meetings and the
communication between the Parties under this Agreement, including the resolution
(in accordance with the terms of this Agreement) of issues between the Parties
that arise in connection with this Agreement.  The Alliance Managers shall not
have final decision-making authority with respect to any matter under this
Agreement.

2.8General Committee Authority.  Each Committee shall have solely the powers
expressly assigned to it in this Article 2 and elsewhere in this Agreement.  No
Committee shall have any power to amend, modify, or waive compliance with this
Agreement (or any agreement entered into in connection with this Agreement).  It
is expressly understood and agreed that the control of decision-making authority
by FibroGen or AstraZeneca, as applicable, pursuant to

25.

 

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Section 2.6, so as to resolve a disagreement or deadlock on a Committee for any
matter will not authorize either Party to perform any function not delegated to
a Committee, and that neither FibroGen nor AstraZeneca shall have any right to
unilaterally modify or amend, or waive its own compliance with, the terms of
this Agreement.

2.9Joint Project Team.  The Parties hereby establish a joint project team (the
“Joint Project Team” or “JPT”) to develop and propose plans to governing
committees, manage operational activities and serve as an information resource
for the Committees.  The members of the JPT representing core functions relevant
to the joint development and commercialization of Products (the “Core Joint
Project Team” or “Core JPT”) shall provide oversight to the overall
JPT.    Until such time as when the JDC and the JCC have been formed, the Core
JPT shall have the additional responsibilities set out in Schedule G(a) and
G(b), respectively. Neither the JPT nor the Core JPT will have any
decision-making authority, except as set out in Schedule G(a) or G(b) or
otherwise explicitly authorized by an appropriate Committee. The Parties agree
to establish a JPT Charter on or prior to October 31, 2014, which contains the
composition and responsibilities of the JPT and the Core JPT. Subject to the JPT
Charter, the Core JPT will consist of project leaders as appointed by FibroGen
and by AstraZeneca, and such additional members as the Parties deem appropriate
from time to time. Each Party will appoint appropriately qualified and
authorized representatives for each applicable operational area or
function.  The JPT members will serve as the point of contact for operational
matters between the Parties.  The JPT may form subteams to support the efforts
of the JPT as agreed by the Parties.  As appropriate, FibroGen may arrange, on
its own initiative or at AstraZeneca’s reasonable request from time to time, a
joint meeting between the JPT and the project team under the Astellas
Collaboration.

2.10Executive Meetings.  FibroGen’s Chief Executive Officer and an appropriate
Executive Vice President of AstraZeneca (or other appropriate representative of
AstraZeneca of equivalent seniority) will meet in advance of the occurrence of
key scheduled Development and Commercialization events or in connection with key
decisions, to review and discuss the status and direction of the Collaboration.

2.11Discontinuation of Participation on a Committee.  Each Committee shall
continue to exist until the first to occur of (a) the Parties mutually agreeing
to disband the Committee, or (b) FibroGen providing to AstraZeneca written
notice of its intention to disband and no longer participate in such Committee,
which FibroGen retains the right to do at any time during the Term, in its sole
discretion, provided, however, that doing so shall not relieve FibroGen of any
of its obligations under this Agreement or the China Agreement (save from the
obligation to participate at the relevant Committee meetings).  Once FibroGen
has provided written notice as referred to in subsection (b) above, such
Committee shall have no further obligations under this Agreement and AstraZeneca
shall have the right to solely decide, without consultation, any matters
previously before such Committee, subject to the other terms of this Agreement.

26.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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ARTICLE 3

Development

3.1Overview.  The Parties agree to undertake a joint development program to
further Develop the Collaboration Compounds and Products as provided in this
Article 3 under the direction of the JDC (or, the JSC prior to the inception of
the JDC),  and pursuant to the Development Plan (such program, the “Development
Program”).  Prior to the JDC’s inception, all references to the JDC in this
Article 3 and elsewhere in this Agreement will be deemed references to the JSC
(which may delegate certain responsibilities to the Core JPT in accordance with
Schedule G(a)).

3.2Development Plans.

(a)General.  All Development of any given Product pursuant to this Agreement for
the U.S. and RoW shall be conducted pursuant to a development plan (the
“Development Plan”) that describes (i) the proposed overall program of
Development for the applicable Product and indications in the U.S. and RoW,
including Clinical Trials and Nonclinical Studies, toxicology, formulation,
packaging development, process and analytical development, production of
registration and validation batches, regulatory plans and other elements of
obtaining Regulatory Approval(s) in each applicable country; (ii) the
anticipated start dates and data availability dates of such Clinical Trials,
Nonclinical Studies and CMC development activities, and timelines for key
Regulatory Authority meetings, filing of applications for Regulatory Approval,
and the receipt of Regulatory Approvals and (iii) the respective roles and
responsibilities of each Party in connection with such activities.  The
Development Plan will be associated with a detailed budget for all such
activities conducted by the Parties for the U.S.  In the event of any
inconsistency between the Development Plan and this Agreement, the terms of this
Agreement shall prevail.

(b)Initial Development Plan.  The initial Development Plan, along with the
associated Development Budget, describing (among other things) the planned
development of the Product for the CKD Indications for the U.S., is attached
hereto as Exhibit H (the “Initial Development Plan”).  The Initial Development
Plan includes and shall be integrated with those Phase 3 Clinical Trials that
are currently being conducted by FibroGen or Astellas under the U.S. and EU plan
for conducting Phase 3 Clinical Trials of the Product for the CKD Indications
under the Astellas EU Agreement (the “Transatlantic Clinical Development Plan”
or the “TCDP”). FibroGen shall notify AstraZeneca, via the JDC, of all material
updates and material changes to the TCDP. The Initial Development Plan shall
further outline such additional Phase 3 Clinical Trials as the Parties have
agreed to conduct (i.e. in addition to those being conducted under the TCDP).
Within thirty (30) days after the Effective Date, the JPT will initiate
implementation of the Initial Development Plan.  

(c)Development Strategy.  Within one (1) year after the Effective Date or at
such other time as the Parties may mutually agree, the JDC will prepare for the
JSC’s review and approval an overall development strategy for the Product in the
Field in the Territory, including

27.

 

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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the CKD Indications for the RoW and any other indications (or other life cycle
management) the Parties are considering to develop (or conduct) throughout the
Territory, which strategy will include anticipated dates (estimated based on the
date of completion of certain development events) for preparing detailed
descriptions of applicable events for inclusion in an amended Development Plan
(the “Development Strategy”).  The Development Strategy will include reasonable
timeframes for any additional indications (i.e., in addition to the CKD
Indications) to be developed hereunder, with the understanding that not all such
indications will be developed concurrently.

(d)Amendments to the Development Plan.

(i)On an annual basis (no later than October 31st of the preceding Calendar
Year), or more often as the Parties deem appropriate, the JDC shall prepare
amendments to the then-current Development Plan and Development Budget for
approval of the JSC.  Each such amended Development Plan shall specify, with a
reasonable level of detail, the items described in Section 3.2(a).  Such amended
Development Plan shall cover the next Calendar Year (and additional periods as
reasonably determined by the Parties) and shall contain a corresponding budget
for U.S. activities.  Such updated and amended Development Plan shall reflect
any changes, re-prioritization of studies within, reallocation of resources with
respect to, or additions to the then-current Development Plan.  In addition, the
JDC may prepare amendments for approval of the JSC to the Development Plan and
corresponding Development Budget from time to time during the Calendar Year in
order to reflect changes in such plan and budget for such Calendar Year, in each
case, in accordance with the foregoing.  At the request of either Party, but no
more frequently than quarterly, the JDC shall review the Development Budget and
propose any necessary amendments to the JSC for approval.  Once approved by the
JSC, the amended annual Development Plan and Development Budget shall become
effective for the applicable period on the date approved by the JSC (or such
other date as the JSC shall specify).  Any JSC-approved amended Development Plan
and Development Budget shall supersede the previous Development Plan and
Development Budget for the applicable period.

(ii)Each Party shall notify the other Party promptly upon becoming aware that it
is likely to exceed, or has exceeded, the budget for a particular activity for
U.S. Development of the Product allocated to such Party in the Development
Plan.  Thereafter, the JDC shall promptly meet and determine whether to amend
the Development Plan or Development Budget accordingly, provided that the JDC
shall not unreasonably withhold its agreement to any budget amendment proposed
by either Party that results from causes outside of such Party’s reasonable
control or that the Parties agree includes expenses reasonably incurred in the
performance of the Development Plan.  Any such amendment proposed by the JDC
shall not be subject to the JSC’s review and will be deemed automatically
approved by the JSC, unless such amendment would cause the total Development
Costs incurred by a Party in any Calendar Year to exceed [ * ] percent [ * ]%)
of the budgeted Development Costs for such Party in such Calendar Year, in which
event JSC approval will be required; provided that the JSC shall not
unreasonably withhold its agreement to any budget amendment proposed by either
Party that results from causes outside of such Party’s reasonable control and
that the Parties agree includes expenses reasonably incurred in the performance
of the Development Plan.

28.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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(e)Development Responsibilities.  Unless the Parties agree in writing upon an
alternate allocation of responsibility, the Parties shall have the following
rights and obligations with respect to operational responsibilities under each
Development Plan:

(i)U.S.  Operational responsibility for all studies designed to support
Regulatory Approvals in the U.S. will be shared between the Parties as allocated
in the Development Plan; provided that FibroGen and Astellas (it being agreed
that as between the Parties FibroGen will be responsible for all such activities
conducted by Astellas; provided however, that [ * ] Astellas [ * ] Astellas [ *
] FibroGen [ * ] this Agreement [ * ] FibroGen [ * ] under the Astellas
Agreements with respect to such activities) will be responsible for conducting
the first Phase 3 Clinical Trials (that are included also in the TCDP) of the
Product in the CKD Indications under the Initial Development Plan. For clarity,
the term ‘first Phase 3 Clinical Trials’, as used in this section, shall be the
studies identified as [ * ] in the Initial Development Plan.

(ii)RoW. AstraZeneca shall be solely responsible for all aspects of the
Development of Collaboration Compounds and Products that are solely applicable
to the RoW (which, for clarity, does not include China).

(iii)Development Sharing Period.  During the Development Sharing Period,
FibroGen shall conduct all Development in good faith, and using Commercially
Reasonable Efforts to achieve the then-current timelines in such Development
Plan.

(f)Development Decision-Making.  Except as otherwise expressly provided in this
Agreement, all matters regarding the Development Plan shall be decided by
consensus by the JDC, subject to Section 2.6.

3.3Coordination with Astellas.

(a)AstraZeneca understands and agrees that FibroGen’s and AstraZeneca’s conduct
of certain Development and Commercialization activities for North America
(meaning the U.S., Mexico and Canada) hereunder are subject to the terms of the
Astellas EU Agreement, and that FibroGen’s obligations to Astellas may require
additional procedures, consents or adherence to notification
obligations.  Accordingly, the Parties shall, as applicable, take into
consideration such obligations when formulating the plans for, and coordinate, [
* ], and FibroGen shall use Commercially Reasonable Efforts to obtain [ * ]
Development in the Territory under this Agreement.  [ * ]. Notwithstanding
anything else in this Agreement to the contrary, however, FibroGen shall not be
required to perform (or refrain from performing) any Development activity that
would constitute a violation of its obligations under the Astellas Agreements,
as disclosed to AstraZeneca prior to the Effective Date.

(b)If, [ * ], FibroGen shall promptly notify AstraZeneca and such matter shall
be discussed at a specially convened JSC meeting. In the event that AstraZeneca,
pursuant to Section 3.9, both (i) is not obligated to use Commercially
Reasonable Efforts to Develop such

29.

 

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Product in such indication; and (ii) following notification by FibroGen,
determines that it does not wish to participate in such Development in such
indication, the following shall apply:

(i)FibroGen shall be free to Develop, obtain Regulatory Approval for and
Commercialize such Product in such indication throughout the Territory;

(ii)As between the Parties, such Development and Commercialization shall be
undertaken at FibroGen’s sole cost;

(iii)FibroGen shall use Commercially Reasonable Efforts to ensure that such
Development and Commercialization shall not materially impact AstraZeneca’s
rights under this Agreement (it being understood that such Development and
Commercialization are not considered per se to materially impact AstraZeneca’s
rights under this Agreement);

(iv)The Parties shall, as soon as practicable, discuss in good faith an option
arrangement whereby AstraZeneca may obtain rights to such Product in such
indication at a future decision point.  The Parties shall negotiate in good
faith the terms under which AstraZeneca would obtain such rights, which terms
include [ * ] and [ * ]; and

(v)The Parties shall discuss in good faith, appropriate amendments to the
provisions of this Agreement to reflect such Development and Commercialization
of such Product in such indication by FibroGen, including, without limitation,
amendments to the pharmacovigilance provisions in Section 4.3.  If the Parties
fail to agree on such terms within a reasonable time period, either Party may
refer the matter to the Executive Officers for discussion.

(c)The Parties shall ensure that each amended Development Plan allows for the
conduct of such Clinical Trials as are included in the then current TCDP.  If
the JDC agrees that additional studies (i.e. in addition to those included in
the TCDP) are required for the Product in the CKD Indications for the U.S., then
the Parties shall, where required, [ * ].  FibroGen shall use Commercially
Reasonable Efforts to [ * ], shall use Commercially Reasonable Efforts to [ *
].  

(d)FibroGen shall use Commercially Reasonable Efforts from time to time during
the Term to [ * ] or other rights that AstraZeneca or the Parties reasonably
believe [ * ] in order to allow AstraZeneca to obtain the benefit of its rights
and licenses pursuant to this Agreement.

3.4Development Costs.

(a)Allocation.  The Parties shall share equally all costs and expenses incurred
by or on behalf of either Party to conduct Development of the Product for the
U.S. under the Development Plan during the Development Sharing Period, according
to the terms of Section 8.2, including for supply of Collaboration Compound or
Product in accordance with Article 6, in each case to the extent that such
Development Costs are not borne or reimbursed by Astellas under the Astellas EU
Agreement, provided that FibroGen will timely inform AstraZeneca of any such
costs borne or reimbursed by Astellas.  AstraZeneca shall be responsible for all
costs and expenses it incurs in the conduct of activities under the Development
Plan for the RoW and shall reimburse

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FibroGen for all costs and expenses FibroGen incurs (including Personnel Costs,
the Fully Burdened Cost of Collaboration Compound or Product or comparator drug,
concomitant drug, placebo or other materials used in any Clinical Trial or
Nonclinical Studies, and all other out-of-pocket costs) for activities conducted
by FibroGen (i) for the U.S. after the Development Sharing Period and (ii) for
the RoW, in each case (i) and (ii) under the Development Plan within the
applicable Development Budget (for the U.S.) or budget (for RoW) (subject to
overages described in Section 3.4(b)) and according to the terms of Section 8.2,
together with the reimbursement for supply of Collaboration Compound or Product
in accordance with Article 6. For clarity, all Clinical Trials set out in the
Initial Development Plan shall be deemed to be Development of the Product for
the U.S.

(b)Overage.  Notwithstanding the foregoing in Section 3.4(a), unless otherwise
agreed by the JDC (subject to JSC approval to the extent set forth in Section
3.2(d)(ii)) or by the Parties, either before or after the applicable expense is
incurred (which agreement shall not be unreasonably withheld for any budget
overage outside the applicable Party’s reasonable control and reasonably
incurred in the performance of the Development Plan), for any Calendar Quarter,
each Party will be solely responsible for Development Costs it incurs in excess
of [ * ] percent [ * ]%) of the total amount allocated to such Party’s
activities in such Calendar Quarter in the Development Budget, and for any
Calendar Year, each Party will be solely responsible for Development Costs it
incurs in excess of [ * ] percent [ * ]%) of the total amount allocated to such
Party’s activities in such Calendar Year in the Development Budget, provided
that Development Costs incurred in excess of [ * ]% for the Calendar Quarter or
[ * ]% for the Calendar Year, as applicable, of the amounts so budgeted shall
also be reimbursed if the Parties determine in good faith that such Development
Costs were reasonably incurred in the performance activities under the
Development Plan and that such budget overage was caused by circumstances
outside of such Party’s reasonable control.

3.5Indications Outside the Field.

(a)Inclusion.  If either Party desires to develop a particular Product for an
indication outside the Field, it may propose such indication to the other Party
in writing by providing the other Party with a high-level proposed development
plan for such Product in such indication.  Upon the other Party’s request within
sixty (60) days after receipt of such development plan, the Parties shall meet
to discuss such proposed indication and shall work together in good faith to
generate and gather the necessary information to support such potential
development and to prepare a detailed development plan.  If the Parties agree on
such plan, AstraZeneca shall have the right to include the proposed indication
in the Field, solely with respect to the applicable Product, by written notice
to FibroGen.  If AstraZeneca exercises such right, such indication will be a
“Designated Indication”, the Field will automatically be expanded to include the
Designated Indication (without payment of any additional upfront fees,
milestones or other consideration except those payments already provided for
under this Agreement), the terms of this Agreement (including payment terms and
diligence obligation) will apply to such indication and the JDC shall promptly
prepare a development plan for such indication for review and approval by the
JSC.

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(b)Termination.  The Field will automatically be amended to remove any
Designated Indication upon the occurrence of any of the following events: (a)
the permanent cessation (excluding, for example, suspension, termination or
completion pending further review, consideration or development planning) of all
Clinical Trials by both Parties with respect to such Product for such Designated
Indication prior to Regulatory Approval in any country in the Territory in such
Designated Indication, (b) the termination of all Regulatory Approvals for such
Designated Indication in the Territory without either Party intending or
considering to restore or replace any such Regulatory Approval, or (c) the
decision of the JSC to permanently cease all Commercialization of such Product
in such Designated Indication.

(c)Restriction.  For clarity, Designated Indications are only those indications
outside the Field that AstraZeneca agrees to include in this Agreement.  Except
for Designated Indications pursuant to this Agreement, FibroGen shall not
Develop or Commercialize (directly or indirectly, by license, supply of Product
or otherwise) any Product for any indication outside the Field in the Territory
during the term of this Agreement.

3.6Additional Compounds.

(a)Added by FibroGen.  At any time during the Term, FibroGen may upon written
notice to AstraZeneca include any HIF Compound in the definition of
Collaboration Compound (and Product).  Effective upon such written notice, the
identified HIF Compound shall be deemed a Collaboration Compound, provided that
AstraZeneca shall not have any obligations with respect to such Collaboration
Compound (or Product) under this Agreement unless and until AstraZeneca’s
acceptance thereof through written notice to FibroGen.

(b)Added by Agreement.

(i)If AstraZeneca wishes to include additional HIF Compounds as Collaboration
Compounds (and Products), it may make such a request to FibroGen.  Upon receipt
of such request, FibroGen shall make good faith and diligent efforts to present
to the JSC for review all reasonably relevant data and other information
(excluding chemical structures) Controlled by FibroGen that is related to those
HIF Compounds that it reasonably believes offer substantial clinical benefit
over then-current Collaboration Compounds from its library of HIF Compounds,
including results from any Phase 2 Clinical Trial conducted in the Field.  For
clarity, the foregoing does not impose any obligation on FibroGen to identify or
generate any additional HIF Compounds.

(ii)If AstraZeneca and FibroGen, through the JDC and JSC, agree upon a
development program for any such HIF Compounds, then the Parties shall negotiate
in good faith to agree on any additional consideration to be payable by
AstraZeneca to FibroGen for inclusion of such additional HIF Compounds as
Collaboration Compounds, and upon agreement, will amend this Agreement
accordingly.

(c)Subject to Section 3.3 and to FibroGen’s obligations under the Astellas EU
Agreement, FibroGen will use good faith in designating additional HIF Compounds
as

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Collaboration Compounds pursuant to this Section 3.6, and shall not nominate
additional HIF Compounds for Development in the [ * ] without approval of the
JSC.

3.7Veterinary Applications.  Following the first approval of an NDA for a
Product, the Parties may agree to develop the Product for a veterinary
application. No additional consideration shall be payable by AstraZeneca to
FibroGen with respect to such development.  Upon agreement, the Parties shall
enter into a separate agreement governing such applications or amend this
Agreement accordingly prior to conducting any activities with respect to
veterinary applications.

3.8Research Collaboration.  Upon FibroGen’s request, the Parties will discuss
conducting a research program funded by AstraZeneca and directed toward
franchise enhancement and lifecycle management for HIF Compounds or other topics
that the Parties determine relevant to the Products and the Field.  Upon
agreement on the terms of such research program, the Parties will enter into a
separate agreement or amend this Agreement accordingly.

3.9Diligence; Standards of Conduct.

(a)Each Party shall use Commercially Reasonable Efforts to Develop and obtain
Regulatory Approval for the Products throughout the Territory (i) in the CKD
Indications and (ii) in each [ * ], other indication in the Field and Designated
Indication that [ * ] in the Development Plan.  If at any time there is only one
Collaboration Compound (either because no additional Collaboration Compounds
have been developed or because development of all other Collaboration Compounds
have been terminated), then the foregoing obligation shall be for one Product
only.

(b)Each Party shall use Commercially Reasonable Efforts to carry out the tasks
assigned to it under the Development Plan in a timely and effective manner. Each
Party shall conduct its activities under the Development Plan in a good
scientific manner and in compliance in all material respects with all applicable
laws and regulations. Without prejudice to the aforesaid, the Party responsible
for the conduct of any Clinical Trials hereunder shall perform such Clinical
Trials in a good scientific manner, in compliance with all applicable laws and
regulations, GCP, this Agreement and the Development Plan as well as the
relevant protocol and investigator’s brochure. Such Party shall further require
the principal investigators, study sites and any contractors involved in the
performance of such Clinical Trials to comply with all safety reporting
procedures set forth in the Pharmacovigilance Agreement in connection with their
performance of such Clinical Trials.

3.10Development Data.

(a)Ownership and Disclosure.  FibroGen shall solely own all data, records and
reports generated by or on behalf of either Party in the conduct of Development
activities under this Agreement (collectively, the “Development Data”), and
AstraZeneca hereby assigns, and shall assign, to FibroGen, all of its right,
title and interest in and to the Development Data.  Each Party shall provide
access to and, where practical, copies of the Development Data it (or its
Affiliates or Sublicensees, or Third Parties acting on their behalf) generates
to the other Party

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promptly upon receipt or development thereof, including nonclinical and clinical
data (including raw data), analysis, reports and protocols. With respect to any
data, records and reports, including nonclinical and clinical data (including
raw data), analysis, reports and protocols, generated by or on behalf of
FibroGen [ * ]”), the following shall apply. [ * ]. AstraZeneca shall reimburse
FibroGen for any translation costs, costs for photocopying or other similar
administrative expenses incurred by FibroGen in connection with providing access
to the [ * ].  Each Party will reasonably respond to the other Party’s request
for access to and questions about the Development Data and Astellas Data.  Such
Development Data will be provided in electronic form if requested by the other
Party or reasonably convertible to such electronic form.

(b)Use.  Each Party shall have the right to use the Development Data, and [ * ],
for the purpose of Developing and Commercializing Products in the Field in the
Territory in accordance with the terms of this Agreement and in China in
accordance with the terms of the China Agreement.  [ * ]. AstraZeneca hereby
grants [ * ]. AstraZeneca will take all actions reasonably requested by FibroGen
to enable [ * ], at FibroGen’s cost and expense.  FibroGen hereby grants
AstraZeneca, its Affiliates and Sublicensees a right of access, a right of
reference and a right to use and incorporate all Development Data [ * ] in any
regulatory filings for Products in the Territory. FibroGen will take all actions
reasonably requested by AstraZeneca to enable AstraZeneca and its Affiliates and
Sublicensees to practice such rights, at AstraZeneca’s cost and expense.

3.11Development Records and Reports.  Each Party shall maintain or cause to be
maintained complete and accurate records (in the form of technical notebooks
and/or electronic files where appropriate) of all work conducted by it or on its
behalf under the Development Plan and all Information resulting from such work,
including in the case of FibroGen, records of whether Development Costs are
borne or reimbursed by Astellas under the Astellas EU Agreement.  Such records,
including any electronic files where such Information may also be contained,
shall fully and properly reflect all work done and results achieved in the
performance of the Development Plan in sufficient detail and in good scientific
manner appropriate for patent and regulatory purposes. Such records shall be
retained by such Party for at least five (5) years after the term of this
Agreement or such longer period as may be required by applicable laws.  Each
Party shall have the right to review and copy such records maintained by the
other Party at reasonable times and to obtain access to originals to the extent
needed for patent or regulatory purposes or for other legal proceedings.  Each
Party shall provide the JDC with regular reports, at least annually, detailing
its Development activities under the Development Plan and the results of such
activities.

3.12Subcontracts.  Each Party may perform any of its Development Program
obligations under this Agreement through one or more subcontractors or
consultants, provided that (a) such Party remains responsible for the work
allocated to, and payment to, such subcontractors and consultants as it selects
to the same extent it would if it had done such work itself; (b) the
subcontractor undertakes in writing obligations of confidentiality and non-use
regarding Product Information and Confidential Information, that are
substantially the same as those undertaken by the Parties pursuant to Article 12
hereof, and (c) the subcontractor agrees in writing to assign all intellectual
property developed in the course of performing any such work under the
Development

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Program to the Party retaining such subcontractor.  A Party may also subcontract
work on terms other than those set forth in this Section 3.12, with the prior
approval of the JDC.

ARTICLE 4

Regulatory Matters

4.1Regulatory Filings and Approvals.

(a)In General.  The Parties intend that the Development Plan will set forth the
regulatory strategy for seeking Regulatory Approvals (including any pricing and
reimbursement approvals) throughout the Territory for all Products being
Developed.  All decisions regarding regulatory issues shall be made in
accordance with the decision-making rules that are set forth in Article 2.

(b)Rights and Obligations.

(i)Lead Regulatory Party.  The lead regulatory Party, on a
jurisdiction-by-jurisdiction basis, shall be responsible for preparing and
filing all Regulatory Materials, including INDs, shall be the holder of all
Regulatory Approvals in such jurisdiction and will have primary operational
responsibility for interactions with Regulatory Authorities, including taking
the lead role at all meetings with Regulatory Authorities, subject to the right
of the other Party to attend such meetings, participate in such activities and
provide input, which the lead regulatory Party will consider in good
faith.  Without limitation, this right of participation covers all regulatory
activities, including development of regulatory strategy and review of
regulatory submissions, attendance at all meetings with Regulatory Authorities
that may potentially impact the Development of or registration package for a
particular Product, and review of outcomes of such meetings.

(ii)U.S.  FibroGen shall be the lead regulatory Party in the U.S. with respect
to each Product and each indication through approval of the first NDA or
supplemental NDA for such Product and indication.  The Parties shall cooperate
in maintaining each IND and preparing and submitting each NDA and applying for
Regulatory Approval in the U.S.  Following such approval, FibroGen will assign
and transfer each such approved NDA or supplemental NDA to AstraZeneca (but not
the ownership of Development Data therein, which shall be retained by FibroGen
pursuant to Section 3.10(a)), and AstraZeneca will become the lead regulatory
Party for such Product and indication in the U.S.; provided that (A) FibroGen
will remain the lead regulatory Party with respect to the CMC section of each
NDA for so long as FibroGen is conducting manufacturing activities under this
Agreement, and (B) FibroGen will continue to have access to all information in
each NDA. FibroGen shall duly execute and deliver, or cause to be duly executed
and delivered, such instruments and shall do and cause to be done such acts,
including the filing of such assignments, agreements, documents and instruments,
as may be reasonably necessary to effectively complete such assignment and
transfer of such approved NDA or supplemental NDA to AstraZeneca.  Each Party
shall provide reasonable cooperation,  information and other support to the
other Party with respect to such other Party’s obligations to comply with
regulatory

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requirements, regardless of whether such other Party is the lead regulatory
Party, including following the transfer of an NDA to AstraZeneca following
Regulatory Approval.

(iii)RoW. AstraZeneca shall be the lead regulatory Party in the RoW for all
Products and indications.

(c)Reporting and Review.

(i)The JPT or JDC shall develop and implement procedures for drafting and review
of material Regulatory Materials for Products in the Territory, which shall
provide sufficient time (at least one week) for each Party to provide
substantive comments prior to the filing of such Regulatory Materials (with
material regulatory filings, or regulatory filings that materially change
existing regulatory filings, subject to prior approval by the JPT or, when
formed, the JDC or the JSC pursuant to Section 2.2(c)(ix) or Section 2.3(b)(xv),
as applicable).

(ii)Each Party shall promptly notify the other Party of all Regulatory Materials
that it submits for Products anywhere in the Territory and shall promptly (and
in any event within one week) provide the non-responsible Party with a copy
(which may be wholly or partly in electronic form) of such Regulatory
Materials.  The lead regulatory Party will provide the non-responsible Party
with reasonable advance notice of any scheduled meeting with any Regulatory
Authority and/or any Regulatory Materials with respect to Products throughout
the Territory, and the non-responsible Party shall have the right to participate
in any such meeting, except to the extent prohibited under applicable law and
regulations.  Representatives of the Party primarily responsible for such
Regulatory Materials will be the primary spokespeople at any such meeting.  The
Party primarily responsible for such Regulatory Materials also shall promptly
furnish the non-responsible Party with copies of all material correspondence to
or from, and minutes of material meetings with, any Regulatory Authority
relating to Development of such Product.

4.2Notification of Threatened Action.  Each Party shall immediately notify the
other Party of any information it receives regarding any threatened or pending
action, inspection or communication by or from any Third Party, including a
Regulatory Authority, which may materially affect the Development,
Commercialization or regulatory status of a Product, whether in or outside the
Territory.  Upon receipt of such information, the Parties shall consult with
each other in an effort to arrive at a mutually acceptable procedure for taking
appropriate action.

4.3Adverse Event Reporting and Safety Data Exchange.  At a time determined by
the JSC, but in any event prior to the  first to occur of (i) the commencement
of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the
first NDA in the U.S. to AstraZeneca, the Parties shall define and finalize the
methods and procedures (based on and consistent where possible with those
methods and procedures used by Astellas and FibroGen under the Astellas EU
Agreement, unless otherwise mutually agreed) that the Parties shall employ with
respect to Products to protect patient safety and promote the appropriate
treatment of safety information of Products in a written pharmacovigilance
agreement (the “Pharmacovigilance Agreement”). For clarity, the
Pharmacovigilance Agreement shall include all relevant safety data regarding the
Product, irrespective of territory or indication. These responsibilities shall
include mutually

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acceptable guidelines and procedures for the receipt, investigation,
recordation, communication, and exchange (as between the Parties) of adverse
event reports, pregnancy reports, and any other information concerning the
safety of any Product.  Such guidelines and procedures shall be in accordance
with, and enable the Parties to fulfill, local and national regulatory reporting
obligations under applicable laws and regulations.  Furthermore, such agreed
procedure shall be consistent with GCP and relevant ICH guidelines, except where
such guidelines may conflict with existing local regulatory reporting or safety
reporting requirements, in which case the local reporting requirements shall
prevail.  FibroGen shall maintain a global safety database for the Products, the
expenses for which will be included in Development Costs and reimbursed by
AstraZeneca, to the extent not borne or reimbursed by Astellas. Each Party
hereby agrees to comply with its respective obligations under such
Pharmacovigilance Agreement and to cause its Affiliates and permitted
sublicensees to comply with such obligations.  If and to the extent necessary,
the Pharmacovigilance Agreement shall be amended by the Parties, or shall be
superseded, so that an appropriate commercial-stage pharmacovigilance agreement
is in place in advance of the first NDA approval for a Product.

4.4Product Withdrawals and Recalls.  If any Regulatory Authority in or outside
the Territory (a) threatens, initiates or advises any action to remove any
Product from the market or (b) requires or advises FibroGen, AstraZeneca, or any
of their respective Affiliates or Sublicensees to distribute a “Dear Doctor”
letter or its equivalent regarding use of such Product, then FibroGen or
AstraZeneca, as applicable, shall notify the other Party of such event within
three (3) Business Days (or sooner if required by law) after such Party becomes
aware of the action, threat, advice or requirement (as applicable).  The JSC
will discuss and attempt to agree upon whether to recall or withdraw a Product;
provided, however, that if the Parties fail to agree within an appropriate time
period, the Party who is the then-holder of the NDA for the Product at issue
shall decide whether to recall or withdraw such Product. AstraZeneca shall be
responsible, at its sole expense, for conducting any recalls or taking such
other necessary remedial action in the Territory, except that FibroGen will be
responsible for such expenses to the extent (i) resulting from the failure of
any Product supplied by FibroGen to conform to the applicable specifications; or
(ii) such recall results from an event outside the Territory and outside the
territory licensed under the China Agreement.

ARTICLE 5

Commercialization

5.1Overview.  The Parties agree to collaborate with respect to the
Commercialization of Products in the Field in the U.S. as provided in this
Article 5 under the direction of the JCC, and pursuant to the U.S.
Commercialization Plan applicable to each Product. AstraZeneca shall have the
sole right and responsibility for Commercializing Products in the Field in the
RoW under the direction of the JCC, in accordance with this Agreement and as
provided in this Article 5.  Prior to the JCC’s inception, all references to the
JCC in this Article 5 and elsewhere in this Agreement will be deemed references
to the JSC (which may delegate certain responsibilities to the Core JPT in
accordance with Schedule G(b)).

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5.2U.S. Commercialization Plan.  As further described in this Section 5.2, the
comprehensive strategy for the Commercialization of each Product in the U.S.
shall be described in a comprehensive plan that describes the pre-launch, launch
and subsequent Commercialization of such Product in the U.S. (including without
limitation the high level strategies regarding messaging, branding, pricing,
advertising, planning, marketing, sales force training and allocation, and
reimbursement/managed care), key tactics for implementing those activities and
the relative responsibilities of the Parties (each such plan, a “U.S.
Commercialization Plan”), and the associated budget for such activities that
details the anticipated Commercialization Costs (each such budget, a “U.S.
Commercialization Budget”).

(a)Promptly after the Effective Date, the JCC (or if not formed, the JSC) will
determine the initial pre-commercial activities for which AstraZeneca will
prepare an initial U.S. Commercialization Plan, which activities will include [
* ], but need not include all activities described in the first paragraph of
this Section 5.2.  Within ninety (90) days thereafter, AstraZeneca will present
such plan to the JCC for review and approval.  Within two (2) years after the
Effective Date but in any event not later than two (2) years prior to the then
currently anticipated NDA submission date, AstraZeneca will present to the JCC a
U.S. Commercialization Plan covering all activities described in the first
paragraph of this Section 5.2, for review and approval by the JCC, which plan
will include the key prelaunch and launch activities, marketing and sales
deployment required for the initial launch of the Product and associated
budgets.  The JCC shall review, revise and recommend for approval by the JSC
such U.S. Commercialization Plan promptly after receipt thereof.  If the JCC is
not yet formed by any of the foregoing dates, the JSC will review, revise and
approve the applicable U.S. Commercialization Plan.

(b)AstraZeneca will prepare a detailed U.S. Commercialization Plan and U.S.
Commercialization Budget in preparation for U.S. launch of the Product for
review and approval by the JCC no later than the submission of the first NDA for
the Product, or at such other time determined by the JSC.

(c)All U.S. Commercialization Plans and U.S. Commercialization Budgets with
respect to Products in the U.S. and subsequent revisions thereto will contain
such information as the JCC believes necessary for the successful
Commercialization of such Product in the U.S., both pre- and post-launch, and
shall generally conform to the level of detail utilized by AstraZeneca in
preparation of its own product commercialization plans.  On an annual basis (no
later than October 31st of the preceding Calendar Year), or more often as the
Parties deem appropriate, the JCC shall prepare amendments to the then-current
U.S. Commercialization Plan(s) and the corresponding U.S. Commercialization
Budgets.  In the event of any inconsistency between a U.S. Commercialization
Plan and this Agreement, the terms of this Agreement shall prevail.  Each Party
shall conduct its activities under the U.S. Commercialization Plan in compliance
in all material respects with all applicable laws and regulations.

5.3RoW Commercialization Plans. AstraZeneca shall prepare Commercialization
plans with respect to Products in the RoW on an annual basis, shall submit such
plans to the JCC for review and approval, and shall respond in a timely fashion
to any reasonable requests of FibroGen or the JCC with respect to such plans and
Commercialization activities in the RoW.

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5.4Commercialization Costs.  AstraZeneca shall be solely responsible for all
Commercialization Costs incurred by it or by or on behalf of FibroGen under the
Co-Commercialization Agreement and in the Commercialization of Products in the
U.S. and RoW.  AstraZeneca will reimburse FibroGen for such costs incurred by
FibroGen, plus a markup of [ * ]) to be applied to FibroGen’s [ * ] costs only,
all pursuant to more detailed provisions to be included in the
Co-Commercialization Agreement.

5.5Sales and Distribution; Returns; Customer Support. AstraZeneca shall be
solely responsible for handling all returns, recalls, order processing,
invoicing and collection, booking of sales, distribution, and inventory and
receivables for Products in the Territory.  FibroGen shall not accept orders for
Products or make sales for its own account or for AstraZeneca’s account, and if
FibroGen receives any order for Products in the Territory, it shall refer such
orders to AstraZeneca for acceptance or rejection. AstraZeneca shall be
responsible for handling all returns of any Product.  If Products are returned
to FibroGen, FibroGen shall promptly ship such Products to
AstraZeneca.  FibroGen, if requested by AstraZeneca, shall advise the customer
who made the return that the Products have been returned to AstraZeneca.
AstraZeneca shall be responsible for providing customer support, handling
medical queries, and responding to product and medical complaints relating to
Products.

5.6Commercialization Reports.  Each Party shall keep the JCC fully informed
regarding the progress and results of Commercialization activities for Products
in the U.S. and RoW, including an annual review of results versus plans (as set
forth in the U.S. Commercialization Plan(s)).

5.7Samples.  At a time determined by the JSC, the Parties will discuss in good
faith whether, how, and under what circumstances the Parties would allow
distribution of samples (i.e., Products provided free of or for a nominal
charge) of Product for treatment of anemia in patients with chronic kidney
disease not undergoing dialysis, or in other applicable indications outside of
the CKD Indications.  Neither Party will have the right to distribute Product
samples without the prior written consent of the other Party, and, if such
consent is granted, each Party will distribute such samples only according to
the procedures and in the amounts agreed by the Parties in writing.

5.8Commercialization Standards of Conduct.

(a)Execution of U.S. Commercialization Plan.  Each Party shall use Commercially
Reasonable Efforts to carry out the tasks assigned to it under the U.S.
Commercialization Plan and the Co-Commercialization Agreement in a timely and
effective manner and in compliance with all applicable laws and regulations.

(b)AstraZeneca Diligence Obligations. AstraZeneca shall use Commercially
Reasonable Efforts to Commercialize each Product in each indication and country
in the Territory for which Regulatory Approval is obtained, except for
indications and countries for which FibroGen has independently obtained
Regulatory Approval, without opt-in by AstraZeneca, under Section 3.3(b).

39.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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5.9Subcontracts.  Each Party may perform any of its obligations under the U.S.
Commercialization Plan through one or more subcontractors or consultants,
provided that (a) AstraZeneca will not subcontract any such activities without [
* ]; (b) such Party remains responsible for the work allocated to, and payment
to, such subcontractors and consultants as it selects to the same extent it
would if it had done such work itself; (c) the subcontractor undertakes in
writing obligations of confidentiality and non-use regarding Product Information
and Confidential Information, that are substantially the same as those
undertaken by the Parties pursuant to Article 12 hereof, and (d) the
subcontractor agrees in writing to assign all intellectual property developed in
the course of performing any such work under the U.S. Commercialization Plan to
the Party retaining such subcontractor.  A Party may also subcontract work on
terms other than those set forth in this Section 5.9, with the prior approval of
the JCC.  AstraZeneca will have [ * ] (subject to compliance with clauses (b) –
(d) of this Section 5.9), except that AstraZeneca will be required to reasonably
[ * ] Third Party subcontractors for such activity.

5.10Co-Commercialization Agreement.  Following submission of the first NDA for a
Product or at such earlier time as AstraZeneca may request, the Parties will
negotiate and enter into an agreement (the “Co-Commercialization Agreement”)
governing the Parties’ conduct of activities for Commercializing the Product in
the U.S.  The Co-Commercialization Agreement will be consistent with the terms
of this Article 5, Exhibit I, other terms agreed by the Parties, and other
customary terms for such an agreement.

5.11Regulatory Compliance.

(a)Each of FibroGen and AstraZeneca shall reasonably cooperate with the other
Party in its efforts toward ensuring that all government reporting (including
price and gift reporting), sales, marketing and promotional practices in respect
of each Product meet the standards required by (A) applicable laws and
regulations; (B) applicable guidelines concerning the advertising and promotion
of prescription drug products, including without limitation the Office of the
Inspector General’s (“OIG”) Compliance Guidance Program issued in 2003, the
American Medical Association (the “AMA”) Guidelines on Gifts to Physicians, the
Pharmaceutical Research and Manufacturers of America Code on Interactions with
Healthcare Professionals, as hereafter amended from time to time (the “PhRMA
Code”), the PhRMA Principles on Conduct of Clinical Trials and Communication of
Clinical Trial Results, and the standards set forth by the Accreditation Council
for Continuing Medical Education relating to educating the medical community in
the United States (“ACCME Standards”); (C) the Prescription Drug Marketing Act
of 1987, as amended, and the rules, regulations and guidelines promulgated
thereunder; (D) federal, state and local agencies and all payor “fraud and
abuse”, and consumer protection and false claims statutes and regulations,
including the Medicare and State Health Programs Anti-Kickback Law (42 U.S.C.
§1320a-7b(b)) and the Safe Harbor Regulations which are found at 42 C.F.R.
§1001.952 et seq.; and (E) the FCPA.  The Parties shall cooperate in good faith
to update their obligations under this Section 5.11(a) from time to time to
reflect any changes in any of the foregoing (A) – (E) or to resolve any
conflicts in any of the foregoing standards as applied to the Parties’
activities under this Agreement.

40.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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(b)Each Party shall be responsible for tracking and reporting transfers of value
initiated and controlled by its employees and/or contractors pursuant to the
requirements of Section 6002 (Transparency Reports and Reporting of Physician
Ownership and Investment Interest) of the Affordable Care Act, commonly referred
to as the “Sunshine Act”, and state marketing reporting laws.  The value
reported to the Centers for Medicare & Medicaid Services shall be the amount
expended by the controlling Party, irrespective of the division of or
reconciliation of expenses between the Parties.

(c)AstraZeneca shall provide its sales representatives appropriate training on
proper marketing and sales techniques.  Such training will include, among other
topics, FDA requirements and other state and federal regulations and guidelines
concerning the advertising of prescription drug products, the OIG Compliance
Guidance Program, the AMA Guidelines on Gifts to Physicians, the PhRMA Code, and
the ACCME Standards.  If requested by FibroGen, AstraZeneca shall provide a
written description of the training to FibroGen no less frequently than on an
annual basis.

(d)Each of FibroGen and AstraZeneca shall reasonably cooperate with the other
Party to provide the other Party access to any and all information, data and
reports required by the other in order to comply with the relevant provisions of
the Medicare Modernization Act and any other applicable laws and regulations,
including without limitation reporting requirements, in a timely and appropriate
manner. AstraZeneca shall ensure that its reporting to the Centers for Medicare
and Medicaid Services and other federal and state healthcare programs related to
the Products is true, complete and correct in all respects; provided however,
that AstraZeneca shall not be held responsible for submitting erroneous reports
if such deficiencies result from information provided by FibroGen which itself
was not true, complete and correct.

(e)AstraZeneca shall, so far as practicable, provide to FibroGen in advance any
submission containing any information provided by FibroGen pursuant to this
Section 5.11 that AstraZeneca proposes to submit to any governmental entity.
AstraZeneca further agrees to seek confidential treatment of any such
information related to FibroGen that it submits to any governmental entity to
the extent permitted under any applicable laws and regulations.

(f)FibroGen and AstraZeneca shall confer with each other on a regular basis to
discuss and compare their respective procedures and methodologies relating to
each Party’s compliance to any applicable laws or regulations or fulfillment of
any other obligation contained in this Section 5.11.  In the event that the
parties have different understandings or interpretations of this Section 5.11 or
of the applicability of, or standards required by, any applicable laws or
regulations, then the Parties shall confer and seek to reach common agreement on
such matters.

(g)Each of AstraZeneca and (where applicable) FibroGen agrees that:

(i)it will instruct its sales representatives to use, and will use Commercially
Reasonable Efforts to train and monitor its sales representatives to ensure that
such sales representatives use, only Promotional Materials and literature
approved for use under subsection (h) of Exhibit I for the promotion of the
Products in the U.S.;

41.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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(ii)it will instruct its sales representatives not to misbrand, change, alter or
adulterate any Promotional Materials supplied to it in any way prior to or
during their distribution or use; and

(iii)it will instruct its sales representatives to do, and will use Commercially
Reasonable Efforts to train its sales representatives to do, and will establish
appropriate internal systems, policies and procedures for the monitoring of its
sales representatives with the goal of ensuring that such personnel do, the
following:

(1)limit claims of efficacy and safety for the Products to those that are (A)
consistent with approved promotional claims in, and not add, delete or modify
claims of efficacy and safety in the promotion of such Products in any respect
from those claims of efficacy and safety that are contained in, the then
effective U.S. Commercialization Plan, (B) consistent with applicable laws and
regulations, and (C) consistent with the Product labeling approved by the FDA;

(2)not make any changes in Promotional Materials, and use Promotional Materials
within the U.S. only in a manner that is consistent with (A) the then effective
U.S. Commercialization Plan, (B) applicable laws and regulations and (C) the
Product labeling approved by the FDA;

(3)promote the Products in compliance with applicable legal and professional
standards that are generally accepted by the pharmaceutical industry in the
applicable market, including applicable laws and regulations and the applicable
guidelines concerning the advertising and promotion of prescription drug
products described in this Section 5.11; and

(4)not to, directly or indirectly, pay, promise to pay, or authorize the payment
of any money, or give, promise to give, or authorize the giving of anything of
value to any official or employee of any Governmental Authority, or to any
political party, or official thereof, or to any candidate for political office
(including any party, official, or candidate) for the purpose of promoting the
sale or improper use of a Product.

ARTICLE 6

Manufacture and Supply

6.1Purchase and Supply Commitment. AstraZeneca hereby appoints FibroGen as its
exclusive supplier of Product (drug substance and drug product) for the
Territory for use in accordance with the terms of this Agreement.  AstraZeneca
agrees to purchase, and FibroGen agrees to supply, all of AstraZeneca’s and its
Affiliates’ and their respective Sublicensees’ requirements of Product (as bulk
drug product and drug substance) for Development and Commercialization in the
Territory under the terms of this Article 6. AstraZeneca shall have the
exclusive right to perform (itself or through its Affiliates, Sublicensees or
Distributors) and shall be solely responsible for final product labeling and
secondary packaging for sale to end users in the Territory.  To the extent that
such labeling and packaging are relevant to FibroGen’s activities

42.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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to seek and obtain Regulatory Approval for the Product, AstraZeneca will
reasonably and timely cooperate with FibroGen, in a manner sufficient to enable
FibroGen to receive Regulatory Approval and to provide materials and Information
as requested by FibroGen.  The right of FibroGen to manufacture on behalf of
AstraZeneca contemplates that at a time to be determined by the JSC, and in any
event before the point in time when [ * ] in any twelve (12) month period,
AstraZeneca will have the right to select, or obligate FibroGen to select, a
second supplier (which may be AstraZeneca itself), and FibroGen will have the
obligation to complete activities to undertake technology transfer in order for
such secondary source to establish and secure regulatory approval as a second
source for drug substance for Product, which shall in any event not limit
FibroGen’s right to continue to ensure that a source of Product be maintained in
the U.S. in order to satisfy FibroGen’s obligations under the Astellas
Agreements and the DFCI Agreement.  For clarity, FibroGen shall have the right
to manufacture Product outside the Territory to fulfill its supply obligations
under this Agreement.  For clarity, subject to the terms of this Agreement,
FibroGen shall have the right to satisfy its obligations under this Article 6
through a Third Party contract manufacturer.  In connection with FibroGen’s
manufacture of Products for use under this Agreement, FibroGen shall have the
right to manufacture in the Territory for supply of Products under the Astellas
Agreements.

6.2Development Supply.  In connection with the supply of any Product for
non-commercial use, FibroGen shall supply Product in compliance with applicable
law and regulations, including GMP requirements, and in accordance with
forecasts set forth in the Development Plan or, if not specified therein, the
forecasts developed by the JDC as necessary for the conduct of Clinical Trials
set forth in the Development Plan.  FibroGen shall use Commercially Reasonable
Efforts to meet any applicable timelines for supplying Product, subject to the
reasonable lead time requirements of Third Party contract manufacturers.
AstraZeneca will pay FibroGen’s Fully Burdened Cost for all Product supplied for
Development, within forty-five (45) days after receipt of invoice therefor.  All
Products supplied for a country after Regulatory Approval in such country will
be considered to be for commercial use, unless used specifically for Clinical
Trials under the Development Plan.  The terms of supply by FibroGen to
AstraZeneca for use in any Clinical Trial conducted under the sponsorship of
AstraZeneca or for other non-commercial use by or on behalf of AstraZeneca, are
as set forth on Exhibit J.

6.3Commercial Supply Agreement.  At a time specified by AstraZeneca, but in any
event in a reasonable period in advance of the anticipated launch date for the
Product in the U.S., the Parties will negotiate in good faith and enter into
separate supply and quality agreements governing the commercial supply of
Product (in bulk and primary packaged forms) from FibroGen to AstraZeneca
(together, the “Supply and Quality Agreement”).  The Supply and Quality
Agreement will include the terms and conditions set forth on Exhibit K and
contain such further customary and commercially reasonable terms governing
similar supply arrangements and other terms as the Parties may agree, including
appropriate forecasting and firm purchase order lead times, taking into
consideration the reasonable notice requirements of FibroGen as well as any
other terms set forth in this Article 6.  The initial Supply and Quality
Agreement shall have a term of [ * ]) years for the supply of drug substance,
after which AstraZeneca would have the right to extend the term for an
additional [ * ] years or to assume responsibility for drug substance
manufacture upon agreement of terms mutually agreed by the Parties, including [
* ] in the form

43.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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of drug substance.  Under the Supply and Quality Agreement, the obligation to
supply drug product shall have a term of five (5) years, which will
automatically renew for succeeding five (5)-year terms and will include the
price applicable pursuant to Section 6.5.  In the event of any inconsistency
between the Supply and Quality Agreement and Article 6 of this Agreement with
regard to matters relating to supply, quality control and quality assurance, the
terms of the Supply and Quality Agreement shall prevail.

6.4Contract Manufacture Process.  FibroGen is currently utilizing a contract
manufacturer to fulfill its manufacturing timelines to complete drug product
development in time for the expected commercial launch of the Product in the
U.S. and under the Astellas Agreements. Notwithstanding the provisions of
Section 6.3, upon AstraZeneca’s written request to FibroGen, not to be submitted
earlier than six (6) months after the Effective Date, the Parties will discuss
in good faith whether to select a separate contract manufacturer mutually
acceptable to the Parties to be used for formulation and bulk drug product
manufacture (using drug substance supplied by FibroGen) for commercial supply
under this Agreement. The Parties shall discuss in good faith the transfer,
including timely technology transfer, as soon as practicable following such
mutual agreement. Such selection will be conducted in accordance with the
following process: As soon as reasonably practicable following AstraZeneca’s
request, the Parties will afford an opportunity for at least two (2) different
Third Party contract manufacturers that are mutually acceptable to the Parties,
consent not to be unreasonably withheld, to submit bids to conduct such
manufacture. Such bids shall be based on a request for quotation, the contents
of which shall be agreed by the Parties in good faith (and shall contain such
specifications and forecasts as are reasonably necessary for a contract
manufacturer to submit a bid with respect to such manufacture). AstraZeneca and
its Affiliates shall provide a proposal on the same basis as the Third Party
contract manufacturers.  The Parties shall review and assess in good faith the
bids submitted by the Third Party manufacturers and by AstraZeneca or its
Affiliate and shall recommend to the JDC the bid that, on the whole, offers the
most favorable terms for such manufacture based on a reasonable assessment of
the relevant factors, including price, capital requirements, quality, capacity,
capability to maintain continuity of supplies, considerations related to the
supply of Product to Astellas and global supply of Product and overall
timeline.  FibroGen will enter into a supply and quality contract with the Third
Party contract manufacturer, on terms consistent with the selected bid and
otherwise reasonably acceptable to the Parties, or the responsibility to
manufacture shall be transferred to AstraZeneca, as determined by the JDC.   In
the event FibroGen shall contract with AstraZeneca or its Affiliate in
accordance with this Section 6.4, FibroGen shall – as soon as reasonably
practicable after the completion of the selection process – provide the
necessary technology transfer as well as all necessary assistance to obtain
required regulatory approvals, all to enable AstraZeneca or its Affiliate to
conduct the formulation and bulk drug product manufacture (using drug substance
supplied by FibroGen) for supply of Product under this Agreement, and to
Astellas under the Astellas Agreements.  If AstraZeneca is not selected as the
contract manufacturer, then at any time after the [ * ], at AstraZeneca’s
request, the Parties shall [ * ].  For clarity, to the extent that the
alternative formulation and drug product manufacture is transferred to such
Third Party, FibroGen shall have the right to use such source of supply to
satisfy FibroGen’s obligations under the Astellas Agreements.

44.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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6.5Transfer Price.

(a)FibroGen will supply to AstraZeneca (or its designated Affiliate or
Sublicensee) Product for commercial use as drug product at a transfer price
equal to [ * ] during the Calendar Year in which such Product is
delivered.  Notwithstanding the foregoing, in the event that the Parties agree
that AstraZeneca shall supply drug product and FibroGen shall only supply drug
substance, the transfer price for such drug substance shall be [ * ] during the
Calendar Year in which such Product is delivered.

(i)If FibroGen supplies Product as drug product, then not less than thirty (30)
days prior to the beginning of each Calendar Year during which FibroGen will be
supplying product (each a “Delivery Year”), the Parties will calculate a
preliminary transfer price per unit (the “Preliminary Price Per Unit”), which
shall be equal to [ * ] multiplied by the fraction (A)/(B), where (A) shall be
the estimated [ * ] for such Delivery Year and (B) shall be the estimated [ * ]
in the Territory during such Delivery Year (all estimations to be made by the
Parties in good faith).  FibroGen will invoice AstraZeneca upon delivery of each
shipment of product at the Preliminary Price Per Unit and AstraZeneca will pay
for such product at such price within forty-five (45) days after its receipt of
such invoice.  Within forty-five (45) days following the end of each Delivery
Year, the Parties will calculate the definitive transfer price per unit
(“Definitive Price Per Unit”) for such year, which shall be equal to [ * ]
multiplied by the fraction (A)/(B), where (A) shall be the actual [ * ] made
during the Delivery Year and (B) shall be the actual [ * ] in the Territory
during such Delivery Year (excluding [ * ]). If the transfer price for the total
volume of product actually delivered by FibroGen during the Delivery Year at the
Definitive Price Per Unit (the “Total Definitive Price”) exceeds the transfer
price for such volume based on the Preliminary Price Per Unit (the “Total
Preliminary Price”), then AstraZeneca shall pay the difference to FibroGen
within forty-five (45) days after its receipt of an invoice from FibroGen for
such amount. If the Total Preliminary Price exceeds the Total Definitive Price,
FibroGen shall issue a credit note to AstraZeneca for the difference.
AstraZeneca shall be entitled to set off the amount due under the credit note
against any subsequent payments owed by AstraZeneca to FibroGen under this
Agreement (or, in the absence of any such subsequent payments, such credit note
shall be settled by FibroGen within forty-five (45) days after its receipt
thereof).

(ii)If FibroGen supplies Product as drug substance, then the Parties shall
calculate the price for Product according to a process similar to that described
in clause (i) above, except that the multiplier shall be [ * ] during the
Delivery Year.

(b)Potential Cost Reductions.  At either Party’s request during the Term, the
Parties shall discuss and explore potential means of collaborating to reduce the
overall costs of manufacture and supply of Products as drug substance or bulk
drug product under this Agreement, with the understanding that the Parties shall
share the financial benefits of any such cost reductions achieved in a
reasonable manner taking into account to what extent each Party has contributed
to such cost reductions.

(c)Adjustment for Generic Entry.  If at any time FibroGen’s net margin
percentage on any Product supplied to AstraZeneca falls below [ * ]) after a
Generic Product is

45.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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sold in any country in the Territory, FibroGen shall have the right to
renegotiate the manufacturing and supply payment terms under the Supply and
Quality Agreement.  Upon FibroGen’s request, the Parties shall renegotiate
reasonable terms in good faith, taking into account also the overall
profitability of such Product to AstraZeneca.

ARTICLE 7

Licenses And Exclusivity

7.1License to AstraZeneca.

(a)License Grant. Subject to the terms and conditions of this Agreement,
FibroGen hereby grants AstraZeneca (i) a co-exclusive (with FibroGen),
royalty-bearing, sublicensable (solely as permitted in accordance with Section
7.3) license under the FibroGen Technology to Develop (solely in accordance with
the Development Plan) Products in the Field in the Territory and (ii) an
exclusive, royalty-bearing, sublicensable (solely as permitted in accordance
with Section 7.3) license under the FibroGen Technology to Commercialize, to
make and have made (solely for use in the Territory under this Agreement), and
to use, sell, offer for sale, and import Products in the Field in the Territory
(subject, however to a retained right for FibroGen to perform Development and
Commercialization (including manufacturing) activities pursuant to this
Agreement or the China Agreement or under the Astellas Agreements).

(b)DFCI Agreement.

(i)The terms and conditions of Sections [ * ] of the DFCI Agreement are binding
on AstraZeneca in its capacity as a sublicensee of FibroGen under the DFCI
Agreement.

(ii)AstraZeneca acknowledges and agrees that its rights to the FibroGen
Technology that is licensed to FibroGen under the DFCI Agreement are at all
times subject to the applicable terms of the DFCI Agreement.  [ * ].

(iii)FibroGen shall use best efforts to maintain the DFCI Agreement in
effect.  [ * ].

(iv)The license granted in Section 7.1(a) is subject to certain reserved rights
as set forth in Section [ * ] of the DFCI Agreement.

7.2License to FibroGen.  Subject to the terms and conditions of this Agreement,
AstraZeneca hereby grants FibroGen a non-exclusive, worldwide, sublicensable,
royalty-free, fully-paid license, under the AstraZeneca Technology during the
Term, to conduct any and all activities assigned to FibroGen under the
Development Plans and U.S. Commercialization Plans, and to Develop and
Commercialize Products outside the Territory.

46.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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7.3Sublicensing.

(a)Scope of Permissible Sublicensing.  The license granted by FibroGen to
AstraZeneca in Section 7.1 may be sublicensed by AstraZeneca: (i) to an
Affiliate of AstraZeneca without any requirement of consent, provided that such
sublicense to an Affiliate of AstraZeneca shall immediately terminate if and
when such party ceases to be an Affiliate of AstraZeneca, or (ii) where such
sublicense is made to enable a Third Party to provide contract research or
development services or contract manufacturing services for AstraZeneca, its
Affiliates or Sublicensees, without such Third Party being granted the right to
distribute, market or sell a Product, to such Third Party without any
requirement of consent, but upon written notice to FibroGen and subject to
Sections 3.12 and 5.9, and no sooner than twelve (12) days after such notice, or
(iii) otherwise (i.e. other than pursuant to (i) or (ii) above) only with the
prior written consent of FibroGen, not to be unreasonably withheld, and no
sooner than twelve (12) days after such consent is obtained.  It will not be
unreasonable for FibroGen to withhold its consent to a sublicense pursuant to
subsection (iii) above to (1) any entity that [ * ] or (2) any company engaged
in the sales of tobacco or tobacco-related products.  AstraZeneca shall be
liable to FibroGen for the acts or omissions of its Sublicensees, and any breach
of an applicable provision of this Agreement by a Sublicensee shall be deemed to
be a breach by AstraZeneca.

(b)Sublicense Agreements. AstraZeneca shall, in each agreement under which it
grants a sublicense under a license set forth in Section 7.1 (each, a
“Sublicense Agreement”), require the Sublicensee to (A) comply with the
obligations in Section 7.8 (as applied to such Sublicensee and its Affiliates)
and (B) provide the following to FibroGen if this Agreement terminates and to
AstraZeneca if only such Sublicense Agreement terminates: (i) the assignment and
transfer of ownership and possession of all Regulatory Materials and Regulatory
Approvals held or possessed by such Sublicensee (which assignment could also be
directly to AstraZeneca prior to any such termination), and (ii) the assignment
of, or a freely sublicensable exclusive license to, all intellectual property
Controlled by such Sublicensee that covers or embodies a Product or
Collaboration Compound or its respective use, manufacture, sale, or importation
and was created by or on behalf of such Sublicensee during the exercise of its
rights or fulfillment of its obligations pursuant to such Sublicense
Agreement.  Each Sublicense Agreement shall be subject to the applicable terms
and conditions of this Agreement, the DFCI Agreement and any Third Party
licenses sublicensed to the Sublicensee.  AstraZeneca shall include a copy of
the DFCI Agreement in all Sublicense Agreements.  AstraZeneca shall forward a
copy of each Sublicense Agreement (which may be redacted but shall contain all
provisions relevant to this Agreement unredacted) to FibroGen within twenty (20)
days after execution thereof, and FibroGen shall have the right to provide such
copy to DFCI; provided that with respect to any Sublicense Agreement with an
Affiliate of AstraZeneca, AstraZeneca shall only be required to provide such
copy upon FibroGen’s request.  Annually, AstraZeneca shall forward to FibroGen a
copy of the reports received by AstraZeneca from its Sublicensees during the
preceding twelve (12) month period under each Sublicense Agreement as shall be
pertinent to (i) the Sublicensee’s operations under each Sublicense Agreement
and (ii) a royalty accounting under the Sublicense Agreement, in each case
solely to the extent relevant to FibroGen’s rights under this Agreement or (to
the extent different, as notified by FibroGen to AstraZeneca) DFCI’s rights
under the DFCI Agreement.  FibroGen shall have the right to provide each such
report to DFCI. FibroGen shall require DFCI

47.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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to comply with confidentiality and non-use obligations in respect of information
disclosed to DFCI in accordance with this Section 7.3(b), which obligations
shall be substantially the same as those undertaken by the Parties pursuant to
Article 12.

(c)Distributorships.  AstraZeneca shall have the right, in its sole discretion,
to appoint its Affiliates, and AstraZeneca, its Affiliates and its Sublicensees
shall have the right, in their sole discretion, to appoint any other person or
entity, in the Territory, to distribute, market and sell the Products, with or
without packaging rights. In circumstances where such appointed person or entity
purchases its requirements of Products from AstraZeneca, its Affiliates or its
Sublicensees, but does not otherwise make any royalty or other payment to
AstraZeneca, its Affiliates or its Sublicensees with respect to intellectual
property rights, and where such person is not an Affiliate of AstraZeneca, then
that person or entity shall be a “Distributor” for purposes of this
Agreement.  The term “packaging rights” in this Section 7.3(c) shall mean the
right for the Distributor to package Products supplied in unpackaged bulk form
into individual ready-for-sale packs.

(d)Co-Promotion.  Subject to Section 5.9, AstraZeneca and its Affiliates shall
have the right, in their sole discretion, to co-promote the Products with any
other person or entity, or to appoint one or more Third Parties to promote the
Products without AstraZeneca in all or any part of the Territory, provided
however that the foregoing shall not adversely impact FibroGen’s right to
co-promote the Product as described under this Agreement.

7.4FibroGen’s Activities.

(a)Covenant by FibroGen.  Except pursuant to this Agreement or the China
Agreement, FibroGen and its Affiliates shall not, and shall not license or
authorize any Third Party to, directly or indirectly,

(i)at any time during the Term Develop or Commercialize any Product in the
Territory within or outside of the Field;

(ii)at any time during the period starting on the Effective Date and continuing
until the earlier to occur of (A) the [ * ] this Agreement and (B) the [ * ]
this Agreement (“Covenant Period 1”) Develop any HIF Compound in any ESA
Indication in the Territory or any indication for which AstraZeneca is
Developing or Commercializing a Collaboration Compound or Product under this
Agreement; and

(iii)at any time during the period starting on the Effective Date and continuing
until the earlier to occur of (A) the [ * ] of this Agreement and (B) the [ * ]
in the Territory (“Covenant Period 2”) Commercialize any HIF Compound in any ESA
Indication in the Territory or any indication for which AstraZeneca is
Developing or Commercializing a Collaboration Compound or Product under this
Agreement.

(b)Astellas Agreements.  [ * ].

48.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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(c)Termination of Astellas Agreements.  Effective upon the termination of either
of the Astellas Agreements with respect to a particular country or countries
(the “Astellas Terminated Territory”), FibroGen hereby grants AstraZeneca a
right of first negotiation to obtain a license to develop and commercialize
Products in the Astellas Terminated Territory, as detailed in this Section
7.4(c).  Accordingly, prior to entering into any agreement with a Third Party
for such purpose, FibroGen shall provide to AstraZeneca a written notice of
FibroGen’s interest in entering into an agreement with respect to the
development and/or commercialization of Products in the Astellas Terminated
Territory.  [ * ].  If the Parties do not reach an agreement with respect to the
grant of such rights with respect to Products in the Astellas Terminated
Territory [ * ] FibroGen shall have no further obligation with respect to the
Astellas Terminated Territory under this Section 7.4(c). Notwithstanding the
foregoing sentence, if FibroGen enters into an agreement with a Third Party (a
“Subsequent Licensee”) with respect to the Products and the Astellas Terminated
Territory (a “Subsequent Agreement”), FibroGen shall ensure that such Subsequent
Agreement does not conflict with the terms of this Agreement and shall use
Commercially Reasonable Efforts to ensure that AstraZeneca [ * ] under such
Subsequent Agreement [ * ], and in any event shall ensure that AstraZeneca’s
rights with respect to the Subsequent Licensee [ * ].

(d)Remedy.  FibroGen hereby acknowledges and agrees that in the event of any
actual or threatened breach of this Section 7.4, AstraZeneca will suffer an
irreparable injury, such that no remedy at law shall afford it adequate
protection against, or appropriate compensation for, such injury.  Accordingly,
FibroGen hereby agrees that AstraZeneca shall be entitled to specific
performance of FibroGen’s obligations under this Section 7.4, as well as such
further timely injunctive relief as may be granted by a court of competent
jurisdiction.

7.5Cross-Territorial Restriction.

(a)AstraZeneca hereby covenants and agrees that it shall not, and will ensure
that its Affiliates and Sublicensees will not, either directly or indirectly,
actively promote, market, distribute, import, sell or have sold Product into
countries outside the Territory.  As to such countries outside the Territory:
(i) AstraZeneca shall not, and will ensure that its Affiliates and Sublicensees
will not, engage in any advertising or promotional activities relating to the
Product directed primarily to customers or other buyers or users of the Product
located in such countries; and (ii) AstraZeneca shall not, and will ensure that
its Affiliates and Sublicensees will not, solicit orders for Products from any
prospective purchaser located in such countries.  If AstraZeneca receives any
order for Products from a prospective purchaser located in a country outside the
Territory from which re-imports into the Territory are unlikely, AstraZeneca
shall immediately refer that order to FibroGen. AstraZeneca shall not accept any
such orders. AstraZeneca may not deliver or tender (or cause to be delivered or
tendered) any Product into a country outside of the Territory from which
re-imports into the Territory are unlikely. AstraZeneca shall not, and will
ensure that its Affiliates and Sublicensees will not, restrict or impede in any
manner FibroGen’s exercise of its retained rights outside the Territory,
provided that any such exercise of rights by FibroGen shall comply with the
terms of this Agreement.

(b)FibroGen hereby covenants and agrees that it shall not and will ensure that
its Affiliates and any Subsequent Licensee shall not, either directly or
indirectly, actively promote,

49.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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market, distribute, import, sell or have sold Product into countries within the
Territory.  As to such countries within the Territory: (i) FibroGen shall not,
and will ensure that its Affiliates and Subsequent Licensees will not, engage in
any advertising or promotional activities relating to the Product directed
primarily to customers or other buyers or users of the Product located in such
countries; and (ii) FibroGen shall not, and will ensure that its Affiliates and
Subsequent Licensees will not, solicit orders for Products from any prospective
purchaser located in such countries.  If FibroGen receives any order for
Products from a prospective purchaser located in a country within the Territory
from which re-imports out from the Territory are unlikely, FibroGen shall
immediately refer that order to AstraZeneca. FibroGen shall not accept any such
orders. FibroGen may not deliver or tender (or cause to be delivered or
tendered) any Product into a country within the Territory from which re-imports
out of the Territory are unlikely. FibroGen shall not, and will ensure that its
Affiliates and Subsequent Licensees will not, restrict or impede in any manner
AstraZeneca’s rights within the Territory, provided that any such exercise of
rights by AstraZeneca shall comply with the terms of this Agreement.  In
addition to the foregoing, FibroGen shall use Commercially Reasonable Efforts to
invoke and enforce the provisions of the Astellas Agreements with respect to
restrictions on supply and commercialization in the Territory.

7.6Negative Covenant.  Each Party covenants that it will not knowingly use or
practice any of the other Party’s intellectual property rights licensed to it
under this Article 7 except for the purposes expressly permitted in the
applicable license grant.

7.7No Implied Licenses.  Except as explicitly set forth in this Agreement,
neither Party grants to the other Party any license, express or implied, under
its intellectual property rights.  This Agreement confers no license or rights
by implication, estoppel, or otherwise under any patent applications or patents
owned in whole or in part by DFCI other than the particular patents and patent
applications licensed under the DFCI Agreement.

7.8Exclusivity.

(a)Restrictive Covenant by AstraZeneca.  Except pursuant to this Agreement or
the China Agreement, AstraZeneca and its Affiliates shall not, and shall not
license or authorize any Third Party to, directly or indirectly,

(i)at any time during Covenant Period 1, or such longer period as may follow
from Section 13.6(i), research or Develop any HIF Compound in the Field; or

(ii)at any time during Covenant Period 2 and three (3) years thereafter,
Commercialize any HIF Compound in the Field and in the Territory.

(b)Acquisition. Notwithstanding the foregoing in Section 7.8(a), neither
AstraZeneca’s nor any of its Affiliates’ direct or indirect acquisition of or
merger with, in whole or in part, a person or entity (or group of companies) or
the business of a person or entity (or group of companies) having any activity
contravening the covenants set forth in Section 7.8(a) shall constitute a breach
of such covenants by AstraZeneca if AstraZeneca or its Affiliate, as the case

50.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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may be, notifies FibroGen within forty-five (45) days following the closing of
such acquisition or merger of its intent to divest itself of such assets and
complies with the following:

(i)AstraZeneca shall ensure that no Development Data, Information related to
Commercialization in connection with this Agreement, FibroGen Technology or
Confidential Information of FibroGen is used in or for the purpose of the
activities contravening such covenants.

(ii)AstraZeneca shall (or, as the case may be, cause its relevant Affiliate to)
[ * ] the sale or transfer to a Third Party of the relevant part of the business
contravening such covenants, and in any case, shall enter into (or, as the case
may be, cause its relevant Affiliate to enter into) a binding definitive
agreement with a Third Party for such sale or transfer no later than [ * ] after
the closing of the acquisition or merger transaction under which the relevant
business was acquired.

(iii)Neither AstraZeneca nor its Affiliates shall, during such [ * ] period,
Commercialize a product being the subject of research or Development activities
forming part of the relevant business which is to be divested, unless such
product was already Commercialized prior to the closing of the acquisition or
merger transaction.

(iv)AstraZeneca shall, notwithstanding anything to the contrary in this Section
7.8(b), at all times continue to be obligated to use Commercially Reasonable
Efforts to Develop or Commercialize a Product in accordance with its obligations
under and subject to Sections 3.9 and 5.8.

(c)Remedy.  AstraZeneca hereby acknowledges and agrees that in the event of any
actual or threatened breach of this Section 7.8, FibroGen will suffer an
irreparable injury, such that no remedy at law shall afford it adequate
protection against, or appropriate compensation for, such injury.  Accordingly,
AstraZeneca hereby agrees that FibroGen shall be entitled to specific
performance of AstraZeneca’s obligations under this Section 7.8, as well as such
further timely injunctive relief as may be granted by a court of competent
jurisdiction.

(d)[ * ].  In the event AstraZeneca or its Affiliates conducts any activities
prohibited under this Section 7.8, any [ * ] shall be subject to the following [
* ].  AstraZeneca [ * ].  Such [ * ] shall be in addition to all other remedies
available to FibroGen.

7.9Additional Provisions Regarding Restrictive Covenants and Exclusivity.

(a)The Parties agree that the restrictions contained in Sections 7.4, 7.5, 7.8
and 13.6(i) are reasonable and necessary for the protection of the Parties’ and
their Affiliates’ respective confidential information and business, that such
restrictions are reasonable in all the circumstances and that the Parties would
not have entered into this Agreement without the protections afforded to them
under Sections 7.4, 7.5, 7.8 and 13.6(i).

(b)The words “Develop” and “Commercialize” and all variations thereof included
in Sections 7.4 and 7.8 with reference to HIF Compounds shall include the
activities

51.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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described in the definitions of such words in Article 1, but with such
activities being with respect to HIF Compounds rather than with respect to a
Product as set forth in the relevant definition.

ARTICLE 8

Financials

8.1License Fees. AstraZeneca shall pay to FibroGen each of the following
non-refundable, non-creditable license fees on or before the applicable date set
forth below; provided that with respect to payment 1, FibroGen shall provide an
invoice on or before the Effective Date, and with respect to payments 2, 3 and
4, FibroGen shall provide an invoice at least forty-five (45) days before each
applicable due date:

 

Number

Due Date

Payment

1

15th Business Day after the Effective Date

$70 million

2

June 30, 2014

$110 million

3

June 30, 2015

$120 million

4

June 30, 2016

$62 million

 

If this Agreement is terminated prior to the due date of payment 2 or 3, then
each such payment shall remain due and payable despite such termination.  If
this Agreement is terminated prior to the due date of payment 4, then payment 4
will remain due and payable despite such termination; [ * ].

8.2Development and Commercialization Cost Reimbursement.

(a)Prior to First NDA Approval during Development Sharing Period.  The following
procedure in this subsection (a) will apply prior to the first NDA approval for
a Product and during the Development Sharing Period.

(i)On or before the Effective Date, FibroGen will submit an invoice to
AstraZeneca for an amount of [ * ] in respect of certain Development Costs
incurred by FibroGen under the Development Plan prior to the Effective Date.
AstraZeneca shall pay such invoice within fifteen (15) Business Days of receipt
of invoice.

(ii)Within twenty (20) days if reasonably possible for AstraZeneca using
reasonable endeavors to meet such timeline and in no event later than twenty
five (25) days after the end of each Calendar Quarter during the Development
Sharing Period, and within fifteen (15) days if reasonably possible for FibroGen
using reasonable endeavors to meet such timeline and in no event later than
twenty (20) days after the end of each Calendar Quarter, the Party shall provide
the other Party with a statement setting forth (A) the actual Development Costs
incurred

52.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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by such Party in such Calendar Quarter,  (B) the Development Costs budgeted for
activities conducted by such Party in such Calendar Quarter under the
Development Plan,  (C) the amount (if any) by which the actual costs differed
from the budgeted costs, subject to the provisions on budget overages in Section
3.4(b), (the “Excess Spend”), (D) the amount carried over from the previous
Calendar Quarters for which the Development Costs incurred by AstraZeneca were
greater than the Development Costs incurred by FibroGen.  As soon as
practicable, and not later than within thirty two (32) days of the end of the
Calendar Quarter, the Parties shall discuss and resolve any issues with respect
to such statements and shall use best efforts to agree the amount owed from one
Party to the other for Development Costs in such Calendar Quarter, so that each
Party bears fifty percent (50%) of the Development Costs incurred (subject to
Section 3.4(b)), provided, however that each Party shall generate any questions
and respond to any inquiries regarding the invoices as promptly as reasonably
possible following receipt, including within forty-eight (48) hours for response
to ordinary inquiries.  Following the reconciliation process for the applicable
Calendar Quarter, and not later than thirty two (32) days of the end of the
Calendar Quarter, each of FibroGen and AstraZeneca shall provide an invoice to
the other Party reflecting fifty percent (50%) of their respective Development
Costs incurred.  Within forty five (45) days after its receipt of such invoice
from FibroGen, if the amount invoiced by FibroGen to AstraZeneca is greater than
the amount invoiced by AstraZeneca to FibroGen, then AstraZeneca shall pay
FibroGen an amount equal the difference between the invoices, subject to the
offset of outstanding Development Costs as detailed below in this Section
8.2(a)(ii). If during the Development Sharing Period and following the quarterly
process set out above, FibroGen owes a payment to AstraZeneca, then no payment
will be made by FibroGen, to AstraZeneca. Instead such amount, in aggregate with
any other such amounts, will be carried forward by AstraZeneca and set off
against any subsequent Development Cost payments owed by AstraZeneca to FibroGen
under this Section 8.2.  For clarity, Development Costs advanced or paid under
this Section 8.2(a)(ii) do not include amounts incurred prior to August 1,
2013.  

(b)Prior to First NDA Approval after the Development Sharing Period.  The
following procedure in this subsection (b) will apply prior to the first NDA
approval for a Product and after the Development Sharing Period.  

(i)No earlier than forty-five (45) days prior to the beginning of each Calendar
Quarter after the Development Sharing Period, FibroGen shall submit to
AstraZeneca an invoice for the Development Costs budgeted to be incurred by
FibroGen to conduct its activities under the Development Plan in such Calendar
Quarter, as adjusted for the Cost Difference as set forth in 8.2(b)(ii)
below.  AstraZeneca shall pay each such invoice within forty-five (45) days
after the invoice date, subject to the offset of Development Cost provisions in
Section 8.2(a).

(ii)No later than twenty (20)) days after the end of each Calendar Quarter after
the Development Sharing Period, FibroGen shall send to AstraZeneca a statement
setting forth (i) the actual Development Costs incurred by FibroGen in such
Calendar Quarter, (ii) the Development Costs budgeted for activities conducted
by FibroGen in such Calendar Quarter in the Development Plan, (iii) the amount
(if any) by which the actual costs differed from the budgeted costs and (iv) the
difference between the amount advanced by AstraZeneca under this Section 8.2(b)
and the Development Costs actually incurred, to the extent below [ * ] percent [
*

53.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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]%) of the budgeted amount (the “Cost Difference”). FibroGen shall adjust the
invoice to be submitted to AstraZeneca under 8.2(b)(i) for the subsequent
Calendar Quarter to account for the Cost Difference.  Not later than within
thirty two (32) days of the end of the Calendar Quarter, the Parties shall
discuss and resolve any issues with respect to such statement and shall use best
effort to agree the amount payable thereunder. If any items not material to
FibroGen’s financial statements remain outstanding at the end of the
reconciliation and resolution process, the parties shall continue to work toward
resolution by the end of following calendar quarter. Notwithstanding anything
else set forth herein, if all amounts invoiced by FibroGen and settled under
Section 8.2(a) exceed fifty per cent (50%) of the difference between the
Development Costs incurred by FibroGen and the Development Costs incurred by
AstraZeneca during the Development Sharing Period (subject to the provisions on
budget overages in Section 3.4(b)), then any such excess may be credited by
AstraZeneca against any subsequent Development Costs payments owed by
AstraZeneca to FibroGen under this Section 8.2(b) and Section 8.2(c), or, in the
event that the Development Costs incurred by FibroGen are no longer being
incurred under this Agreement and are insufficient to make up such excess, such
excess may be credited against any other payments owed by AstraZeneca to
FibroGen under this Agreement, until fully used.

(c)Adjustment in Payment Schedule.  At any time after January 1, 2015 and prior
to the time at which ninety percent (90%) of the targeted enrollment in any CKD
Indication Clinical Trials (conducted by FibroGen and for which FibroGen will be
incurring Development Costs) has been achieved (the “Increased Advance Period”),
upon request of FibroGen, the Parties shall discuss in good faith the upcoming
spending plans for the Development Budget in which FibroGen reasonably
anticipates that significant cost variances, such as those associated with
patient enrollment rates or other reasonably unforeseen causes, may occur with
respect to such CKD Indication Clinical Trials during the next Development
Budget year and thereafter.  The Parties shall agree upon the timing of the
implementation of a further advance in any Calendar Quarter in an upcoming
period during the Increased Advance Period:  If FibroGen reasonably determines
that anticipated spending in respect of such CKD Indication Clinical Trials such
as enrollment rate is proceeding in a manner that the Development Costs for
which advances have been received in a Calendar Quarter under Section 8.2(a) or
(b) will likely be exceeded, then FibroGen shall notify the JSC of the basis for
such anticipated overage and if such overage is anticipated to exceed by [ * ]
percent [ * ]%) or more such budgeted amount, then FibroGen may invoice
AstraZeneca prior to the end of the Calendar Quarter an amount it reasonably
believes is necessary to cover such overage.  AstraZeneca shall pay such amount
within forty-five (45) days of invoice and any such amounts advanced under such
invoice under this Section 8.2(c) shall be deducted from the subsequent payment
under Section 8.2(a), (b) or (d).

(d)Following First NDA Approval.  The following procedure in this subsection (d)
will apply after the first NDA approval for a Product, unless otherwise agreed
by the JDC.  Within thirty (30) days after the end of each Calendar Quarter in
which FibroGen conducts activities under the Development Plan, FibroGen shall
send to AstraZeneca an invoice for all Development Costs incurred by FibroGen in
such Calendar Quarter, up to an amount equal to [ * ] percent ([ * ]%) of the
budgeted amount for the applicable activities. AstraZeneca shall pay each such
invoice within forty-five (45) days after receipt thereof.

54.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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(e)Annual Reconciliation.  Within thirty (30) days after the end of each
Calendar Year in which either Party conducts activities under the Development
Plan, such Party shall send to the other Party a statement setting forth the
Development Costs actually incurred by such Party and the budgeted amounts for
all activities conducted by such Party under the Development Plan during such
Calendar Year; provided that if no part of such Calendar Year was during the
Development Sharing Period, or if only FibroGen is conducting Development
activities, only FibroGen shall be required to provide such
statement.  FibroGen’s statement will also include the Development Costs
incurred by FibroGen and actually reimbursed by Astellas for such Calendar
Year.  If during the Development Sharing Period, such actual amount exceeds the
budgeted amount (or amount otherwise approved by the JSC) by more than [ * ]
percent [ * ]%) of the budgeted amount, then fifty percent (50%) of the excess
(i.e., above [ * ] percent [ * ]%)) will be credited against or added to
(depending on which Party incurred the excess) the subsequent payment from
AstraZeneca to FibroGen under this Section 8.2.  After the Development Sharing
Period, if such actual amount incurred by FibroGen exceeds the budgeted amount
(or amount otherwise approved by the JSC) by more than [ * ] percent [ * ]%) of
the budgeted amount, the excess (i.e., above [ * ] percent ([ * ]%)) will be
credited against the subsequent payment from AstraZeneca to FibroGen under this
Section 8.2.

(f)RoW Activities.  Within thirty (30) days after the end of each Calendar
Quarter in which FibroGen conducts activities under the Development Plan for the
RoW, FibroGen shall send to AstraZeneca an invoice for all costs incurred by
FibroGen in such Calendar Quarter for such activities, including Personnel
Costs, the Fully Burdened Cost of Collaboration Compound or Product or
comparator drug, concomitant drug, placebo or other materials used in any
Clinical Trial or Nonclinical Studies, and all other out-of-pocket costs.
AstraZeneca shall pay each such invoice within forty-five (45) days after
receipt thereof.

(g)Commercialization Cost.  Within thirty (30) days after the end of each
Calendar Quarter in which FibroGen conducts activities under the U.S.
Commercialization Plan, FibroGen shall send to AstraZeneca an invoice for all
Commercialization Costs incurred by FibroGen in such Calendar Quarter.
AstraZeneca shall pay each such invoice within forty-five (45) days after
receipt thereof.

8.3Development Milestone Payments.

(a)Payments. AstraZeneca shall make milestone payments to FibroGen based on
achievement by AstraZeneca, its Affiliate or a Sublicensee (or, if applicable,
by FibroGen) of the development and regulatory milestone events set forth in
this Section 8.3(a) with respect to any indication other than an indication
independently developed by FibroGen pursuant to Section 3.3(b) for which
AstraZeneca does not opt in.

55.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Number

Milestone Event

Payment

1

This milestone event will be deemed achieved on the sixtieth (60th) day after
AstraZeneca’s receipt from FibroGen of the audited final report from the
Carcinogenicity Studies, provided that AstraZeneca has not submitted to FibroGen
a notice of termination of this Agreement for Technical Product Failure within
thirty (30) days after its receipt of such report.

$15 million

2

First acceptance by the FDA for filing of an NDA in the Field in the U.S.

$50 million

3

[ * ]

$[ * ] million

4

[ * ]

$[ * ] million

5

[ * ]

$[ * ] million

6

[ * ]

$[ * ] million

7

[ * ]

$[ * ] million

(b)Clarifications.

(i)With respect to the first milestone event in Section 8.3(a), if AstraZeneca [
* ] within such thirty (30) day period, then (A) this milestone event will be [
* ] and (B) this milestone event will be [ * ].

(ii)Each milestone payment in Section 8.3(a) shall be paid only once, without
regard to whether two or more Products ultimately achieve any such milestone
event.  For the purposes of milestone events no. 5, 6 and 7 in Section 8.3(a),
the Parties agree that the [ * ] shall be regarded as one and the same
indication and thus not constitute [ * ].

(iii)The foregoing milestone events do not include events achieved by the
Product for indications independently developed by FibroGen pursuant to Section
3.3(b) for which AstraZeneca does not opt in.

(c)Notice; Payment. The applicable Party shall notify the other Party upon
achievement of each milestone in Section 8.3(a).  AstraZeneca shall pay to
FibroGen the amounts

56.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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set forth in Section 8.3(a) within forty-five (45) days after receipt by
AstraZeneca of an invoice from FibroGen for the relevant amount, following the
achievement of the applicable milestone event by AstraZeneca, its Affiliate or a
Sublicensee (or, if applicable, by FibroGen).  Each such payment shall be made
by wire transfer of immediately available funds into an account designated by
FibroGen.  Each such payment is nonrefundable and non-creditable against any
other payments due hereunder.

8.4[ * ] Milestone.

(a)Milestone. AstraZeneca shall pay a milestone to FibroGen in the amount of the
discounted value of [ * ])], discounted using ten percent (10%) annual
compounding, applied from the Trigger Date to the Discount Date (each as defined
below) (such value, the [ * ] Milestone”) following the first [ * ] (meaning
that – notwithstanding anything else set forth herein – AstraZeneca shall never
be obligated to pay the Deferred Approval Milestone prior to the [ * ]) as of
the payment date determined in accordance with Section 8.4(b); provided that and
notwithstanding anything else set forth below in this Section 8.4, if any of [ *
]”) on or before [ * ]”) then the [ * ] Milestone will not be payable.  The [ *
] Milestone is nonrefundable and non-creditable against any payments due
hereunder.

(b)Payment Date.  If payable pursuant to Section 8.4(a), the [ * ] Milestone
will be due as follows:

(i)If all [ * ], the “Discount Date” will be the date of first [ * ], and the [
* ] Milestone will be payable within forty-five (45) days thereafter, provided
that there is then no [ * ].

(ii)If [ * ], the “Discount Date” will be January 1 of the Calendar Year
following the Calendar Year in which [ * ], and the [ * ] Milestone will be
payable on the Discount Date, provided that there is then no [ * ].

(iii)If [ * ], but if there is no [ * ], then the [ * ] Milestone (the full
undiscounted amount of [ * ] will be payable on the Trigger Date.

(iv)If any [ * ], the Discount Date will be the later to occur of (a) the date
of [ * ] and (b) the first [ * ], and the [ * ] Milestone will be payable within
forty-five (45) days after the Discount Date.

(v)At any time prior to the Trigger Date, AstraZeneca may elect to pay the [ * ]
Milestone, and the Discount Date will be the date of payment.

(c)Trigger Date.  The “Trigger Date” means [ * ], the date on which such [ * ].
For example, if no [ * ], the Trigger Date is [ * ].  If a [ * ], then the
Trigger Date is [ * ].

57.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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8.5Sales Milestone Payments.

(a)U.S. Events.  AstraZeneca shall make each of the sales milestone payments
indicated below to FibroGen when aggregate Annual Net Sales of all Products
across all indications in the U.S. (other than sales by FibroGen in indications
independently developed by FibroGen pursuant to Section 3.3(b) for which
AstraZeneca does not opt in) first reach the Dollar values indicated below.

 

Aggregate Annual Net Sales in the U.S.

Payment

$[ * ]

$[ * ] million

$[ * ]

$[ * ] million

$[ * ]

$[ * ] million

 

Each milestone in this Section 8.5(a) shall be paid only once.

(b)Additional U.S. Milestones. AstraZeneca shall make each of the sales
milestone payments indicated below to FibroGen when aggregate Annual Net Sales
of Products in LDOs in the U.S. (other than sales by FibroGen in indications
independently developed by FibroGen pursuant to Section 3.3(b) for which
AstraZeneca does not opt in) first reach the Dollar values indicated below in
any Calendar Year from 2018-2022 (inclusive).

 

Aggregate Annual Net Sales to LDOs in the U.S.

Payment

$[ * ]

$[ * ] million

$[ * ]

$[ * ] million

$[ * ]

$[ * ] million

 

(c)RoW Events. AstraZeneca shall make each of the sales milestone payments
indicated below to FibroGen when aggregate Annual Net Sales of all Products
across all indications in the RoW (other than sales by FibroGen in indications
independently developed by

58.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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FibroGen pursuant to Section 3.3(b) for which AstraZeneca does not opt in) first
reach the Dollar values indicated below.

 

Aggregate Annual Net Sales in RoW

Payment

$[ * ]

$[ * ] million

$[ * ]

$[ * ] million

 

Each milestone in this Section 8.5(c) shall be paid only once.

(d)Notice; Payment. AstraZeneca shall notify FibroGen of achievement of each of
the milestone events in this Section 8.5 within forty-five (45) days after the
end of the Calendar Quarter in which achieved.  AstraZeneca will pay to FibroGen
the amounts set forth in Sections 8.5(a), 8.5(b) and 8.5(c) within forty-five
(45) days after AstraZeneca’s receipt of an invoice from FibroGen following the
end of the Calendar Quarter during which the applicable milestone event has been
achieved.  If more than one such milestone is achieved in any Calendar Quarter,
then all applicable payments will be due.  Each such payment shall be made by
wire transfer of immediately available funds into an account designated by
FibroGen.  Each such payment is nonrefundable and non-creditable against any
other payments due hereunder.

8.6Royalties

(a)Royalty Rates. AstraZeneca shall pay to FibroGen non-refundable,
non-creditable royalties on the amount of aggregate Annual Net Sales of each
Product in the Territory as calculated by multiplying the applicable royalty
rates set forth below by the corresponding amount of incremental aggregate
Annual Net Sales in the Territory of such Product in such Calendar Year.  For
clarity, royalties are not due on sales of Products by FibroGen solely in
indications independently developed by FibroGen pursuant to Section 3.3(b) for
which AstraZeneca does not opt in.

 

Aggregate Annual Net Sales
(Per Product)

Royalty Rate

Portion less than $[ * ]

[ * ]%

Portion greater than or equal to $[ * ]

[ * ]%

 

59.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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By way of example, if the aggregate Annual Net Sales of a Product in the
Territory in a particular Calendar Year is two billion five hundred million
Dollars ($2,500,000,000), the amount of royalties payable hereunder shall be as
follows:

$ [ * ]  

$ [ * ]  

[ * ]

(b)Sales Subject to Royalties.  Sales between AstraZeneca, its Affiliates and
Sublicensees shall not be subject to royalties hereunder unless the purchaser is
an end user.  Royalties shall be calculated on AstraZeneca’s, its Affiliates’
and Sublicensees’ sales of the Products to a Third Party, including Distributors
(but excluding for the avoidance of doubt Sublicensees).  Royalties shall be
payable only once for any individual S.K.U. of a Product.  For the purpose of
determining Net Sales, the Product shall be deemed to be sold when invoiced and
a “sale” shall not include, and no royalties shall be payable on, transfers by
AstraZeneca, its Affiliates or Sublicensees of reasonable quantities of clinical
trial materials, or other transfers or dispositions of reasonable quantities of
Products for charitable, promotional, nonclinical, clinical, manufacturing,
testing or qualification, regulatory or governmental purposes in compliance with
this Agreement (it being understood and agreed that neither Party shall have the
right to distribute the Product as samples except pursuant to Section 5.7).

(c)Generic Competition.  If, in any country in the Territory, the Net Sales of
any Product in any rolling four Calendar Quarter period following the first sale
of a Generic Product to such Product in such country is less than [ * ] of the
Net Sales for such Product in such country in the immediately preceding four
Calendar Quarter period, then the royalty rate for such Product in such country
shall be reduced to [ * ] that would otherwise have been applicable under
Section 8.6(a) for Net Sales of such Product in such country.  For clarity, if
the Generic Product is barred or withdrawn from sale in such country and the Net
Sales in such country in any rolling four Calendar Quarter period is greater
than [ * ] of the value for the rolling four quarter period prior to the first
sale of a Generic Product, then the foregoing reduction shall no longer apply
effective as of the Calendar Quarter in which the Generic Product is barred or
withdrawn from sale. The calculation of the royalty reduction under this Section
8.6(c) shall be conducted separately for each Product in each country.  By way
of example, if during the first Calendar Quarter of a particular Calendar Year
in which the foregoing reduction applies, the Net Sales in such Calendar Quarter
in a country in which the foregoing reduction applies are one billion five
hundred million Dollars ($1,500,000,000), and the Net Sales in such Calendar
Quarter in a country in which the foregoing royalty reduction does not apply are
one billion Dollars ($1,000,000,000), the following shall apply with respect to
the royalty payment owed for such Calendar Quarter: The royalty payment without
regard to the reduced rate would be [ * ].

(d)Compulsory Licenses.  If a court or a governmental agency of competent
jurisdiction requires AstraZeneca or its Affiliate or Sublicensee to grant a
compulsory license to a Third Party and if as a result of the compulsory license
the Net Sales of such Product in any rolling

60.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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four Calendar Quarter period following the first grant of such compulsory
license in such country is less than [ * ] of the Net Sales for such Product in
such country in the immediately preceding four Calendar Quarter period, then the
royalty rate for such Product in such country shall be reduced to [ * ] of the
royalty rates (in each tier) that would otherwise have been applicable under
Section 8.6(a) for Net Sales of such Product in such country.  For clarity, to
the extent that the compulsory licenses in the relevant country are duly
terminated or expire in such country and the Net Sales in such country in any
rolling four Calendar Quarter period is greater than [ * ] of the value for the
rolling four quarter period prior to the first grant of the compulsory license
in such country, then the foregoing reduction shall no longer apply effective as
of the Calendar Quarter in which the compulsory license is terminated or
expires. The calculation of the royalty reduction under this Section 8.6(e)
shall be conducted separately for each Product in each country.

(e)Order of Royalty Reduction and Royalty Floor. Any reductions set forth in
Sections 8.6(c), 8.6(d) and 8.8(c) shall be applied in the order in which the
event triggering such reduction occurs, provided that in no event shall, due to
the cumulative reductions set out in Sections 8.6(c) and 8.6(d), the royalty
that would otherwise have been payable to FibroGen under this Section 8.6 in a
particular Calendar Quarter be reduced below [ * ]) of the royalty set forth in
Section 8.6(a).

(f)Royalty Term.  AstraZeneca’s obligation to pay royalties due under this
Section 8.6 with respect to a particular Product in each country in the
Territory will commence upon the First Commercial Sale of such Product in such
country and will be payable for so long as such Product is sold in such country
by AstraZeneca or its Affiliate or Sublicensee.

(g)Royalty Payments and Reports. All amounts payable to FibroGen pursuant to
this Section 8.6 shall be paid in Dollars within forty-five (45) days after the
end of each Calendar Quarter with respect to Net Sales in such Calendar
Quarter.  Each payment of royalties due to FibroGen shall be accompanied by a
statement, on a country-by-country basis, of the amount of gross sales of
Products in the Territory during the applicable Calendar Quarter, a calculation
of Net Sales in the Territory showing the aggregate deductions from gross sales
provided for in the definition of Net Sales during such Calendar Quarter, and a
calculation of the amount of royalty payment due on such sales for such Calendar
Quarter. For the avoidance of doubt, FibroGen acknowledges and agrees that each
statement provided by AstraZeneca under this Section 8.6(g) shall constitute
Confidential Information of AstraZeneca and FibroGen shall comply with its
confidentiality and non-use obligations in respect of such statements as set
forth in Article 12.

(h)Clarification. AstraZeneca acknowledges that it will continue to enjoy
substantial benefit from its license under, and the transfer to AstraZeneca of
certain elements of, the FibroGen Technology pursuant to this Agreement, as well
as from AstraZeneca’s own development of inventions derived from the practice of
such license and AstraZeneca’s use of such FibroGen Technology, even after the
expiration of all FibroGen Patents claiming the Product in a particular country
in which Products are sold.  In addition, AstraZeneca acknowledges that the
application of a uniform royalty structure during the sale of Products is more
convenient to the

61.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Parties, facilitates payments, and reduces accounting burdens on the Parties, as
compared with a payment structure dependent on the expiration of FibroGen
Patents.

8.7FibroGen IPO. AstraZeneca shall make a one-time, non-refundable,
non-creditable payment of [ * ] to FibroGen upon a FibroGen IPO; provided that
(a) if such IPO has not occurred prior to December 1, 2015, AstraZeneca will
make such payment on December 15, 2015, and (b) if the Parties agree upon terms
(and FibroGen undertakes, upon AstraZeneca’s request, to negotiate such terms in
good faith), including a lock-up and standstill agreement (subject to maximum
ownership of [ * ]%), then in lieu of such payment, AstraZeneca will make a [ *
] equity investment in FibroGen at the initial public offering price
simultaneous with the closing of a FibroGen IPO.

8.8Third Party Intellectual Property.

(a)DFCI Agreement.  FibroGen shall be solely responsible for all payments to
DFCI under the DFCI Agreement.

(b)Right to Obtain License.  If either Party desires to obtain a license under
any Third Party’s intellectual property in connection with the Development and
Commercialization of Products, such Party will notify the other Party.  FibroGen
will have the first right (but not the obligation) to obtain such license.  If
FibroGen elects not to obtain such license, or is unsuccessful in doing so, then
AstraZeneca will have the right (but not the obligation) to negotiate and obtain
such license at its sole discretion and expense (but subject to Section
8.8(c)).  The negotiating Party will obtain such license, with the right to
sublicense, in order to permit AstraZeneca to exercise its rights and to perform
its obligations under this Agreement.  Subject to the foregoing, the terms and
conditions involved in obtaining such license shall be determined at such
negotiating Party’s sole discretion.

(c)AstraZeneca Obtains License.  In the event AstraZeneca obtains a license
under any Third Party patents that claim the composition of matter, formulation
(to the extent AstraZeneca is performing any formulation activities, which
activities it may perform only with FibroGen’s prior written consent), method of
treatment or other use of a Collaboration Compound or Product, AstraZeneca shall
provide to FibroGen a copy thereof and shall have the right to offset, against
royalties payable to FibroGen under Section 8.6 for the applicable Product, [ *
] actually paid by AstraZeneca to such Third Party under such license for the
sale of the applicable Product in the applicable country and Calendar Quarter;
provided that the royalties payable to FibroGen for any Product in any Calendar
Quarter under Section 8.6 may not be reduced by more than [ * ] of those
otherwise due to FibroGen under Section 8.6(a) in any Calendar Quarter for such
Product as a result of such offset and other reductions under Section
8.6.  Except as provided above in this subsection (c), AstraZeneca will be
solely responsible for all amounts owed by AstraZeneca or its Affiliates to
Third Parties under a license to intellectual property on account of
AstraZeneca’s or its Affiliates’ manufacture, use, sale, offer for sale, or
import of Products.

(d)FibroGen Obtains License.  Except as provided in subsection (a) above, the
FibroGen Technology licensed to AstraZeneca in this Agreement will include
patents, patent

62.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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applications and Information licensed to FibroGen by a Third Party if (i)
AstraZeneca assumes [ * ] of all payment obligations under such license
agreement to the extent arising out of the use, Development or manufacture of
any Product or Commercialization of any Product by or on behalf of AstraZeneca
in the Territory, as well as all other obligations of such license agreement
that are applicable to AstraZeneca, and (ii) AstraZeneca acknowledges in writing
that its sublicense under such license agreement is subject to the terms and
conditions of such license agreement.  If any such payments are not allocated
among countries, the Parties shall reasonably allocate such payments to within
and outside the Territory in good faith.  

8.9Taxes.

(a)Taxes on Income.  Each Party shall be solely responsible for the payment of
all taxes imposed on its share of income arising directly or indirectly from the
collaborative efforts of the Parties under this Agreement.

(b)Withholding Tax.  The Party making payments under this Agreement (the
“Payor”) to the other Party (the “Payee”) shall deduct or withhold from the
payments any Taxes that it is required by applicable law to deduct or withhold.
The Payee shall provide the Payor any tax forms or appropriate governmental
authorization that may be reasonably necessary in order for Payor to not
withhold tax or to withhold tax at a reduced rate under an applicable bilateral
income tax treaty.  The Payee shall use reasonable efforts to provide any such
tax forms to the Payor at least thirty (30) days prior to the due date for any
payment for which the Payee desires that Payor apply a reduced withholding rate
and in any event at least fifteen (15) days prior to the time the applicable
payment is due.  Each Party shall provide the other with reasonable assistance
to enable the recovery, as permitted by applicable laws and regulations, of
withholding taxes, Indirect Taxes, or similar obligations resulting from
payments made under this Agreement, such recovery to be for the benefit of the
Party bearing such withholding tax or Indirect Taxes.

(c)Payment of Tax.  To the extent the Payor is required by applicable law or
regulations to deduct and withhold taxes on any payment to the Payee, the Payor
shall pay the amounts of such taxes to the proper Governmental Authority in a
timely manner and promptly transmit to the Payee an official tax certificate or
other evidence of such withholding sufficient to enable the Payee to claim such
payment of taxes.

(d)Indirect Tax.  All payments to be made by one Party to another Party,
pursuant to the terms of this Agreement, are stated exclusive of Indirect
Taxes.  If any Indirect Taxes are chargeable in respect of such payments, the
Party making shall payment shall pay such Indirect Taxes at the applicable rate
following the receipt where applicable of an Indirect Taxes invoice in the
appropriate form issued.  Each Party shall issue valid invoices for all amounts
payable under this Agreement consistent with all applicable laws and
irrespective of whether such amounts may be netted for settlement purposes.  The
Parties shall cooperate in accordance with applicable law to minimize Indirect
Taxes.

(e)Imports.  For the avoidance of doubt, the Parties acknowledge and agree that
none of the upfront payments, milestone payments or royalties payable under this
Agreement

63.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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are related to the license (or right) to import or any import of Products.  The
Parties shall cooperate to ensure that the Party responsible for shipping values
Product in accordance with applicable laws and maximizes the full benefits of
available duty free or savings programs and minimizes where permissible any such
duties and any related import taxes that are not reclaimable from the relevant
authorities.  The receiving Party shall be responsible for any import clearance,
including payment of any import duties and similar charges, in connection with
any Products transferred to such Party under this Agreement.

8.10Blocked Currency.  In each country where the local currency is blocked and
cannot be removed from the country, royalties accrued on Net Sales in that
country shall be paid to FibroGen in the equivalent amount in Dollars.

8.11Foreign Exchange.  Conversion of sales or expenses recorded in local
currencies to Dollars will be performed in a manner consistent with each Party’s
normal practices used to prepare its audited financial statements for external
reporting purposes, provided that such practices use a widely accepted source of
published exchange rates.

8.12Late Payments.  If a Party does not receive payment of any sum due to it on
or before the due date therefor, simple interest shall thereafter accrue on the
sum due to such Party from the due date until the date of payment at a rate
equal to the U.S. Prime Rate for the date payment was due as reported by the
Wall Street Journal.

8.13Financial Records; Audits.

(a)Records.  Each Party shall maintain complete and accurate records in
sufficient detail to permit the other Party to confirm the accuracy of the
amount to be reimbursed, pursuant to Section 8.2, with respect to Development
Costs or Commercialization Costs or other amounts to be reimbursed or shared
hereunder incurred or generated (as applicable) by such Party, achievement of
sales milestones, royalty payments and other compensation payable under this
Agreement.  Each Party shall keep or cause its Affiliates to keep such records
for a period of the later of (a) six (6) years after the end of the period to
which such books, records and accounts pertain and (b) the expiration of the
applicable tax statute of limitations (or any extensions thereof), or for such
longer period as may be required by applicable law.  Each Party shall maintain
such records at its principal place of business or the principal place of
business of the appropriate division of such Party to which this Agreement
relates.

(b)Procedure.  Upon reasonable prior notice, such records shall be open during
regular business hours for a period of three (3) years from the creation of
individual records, in each case, for examination at the auditing Party’s
expense, and not more often than once each Calendar Year, by an independent
certified public accountant selected by the auditing Party and reasonably
acceptable to the audited Party (or in the case of audits of AstraZeneca, by
DFCI under the terms of Section 4.2.2 of the DFCI Agreement) for the sole
purpose of verifying for the auditing Party the accuracy of the financial
reports or sales milestone notices furnished by the audited Party pursuant to
this Agreement or of any payments made, or required to be made, by or to the
audited Party to the other pursuant to this Agreement.  Any such auditor shall
not disclose the audited

64.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Party’s Confidential Information to the auditing Party, except to the extent
such disclosure is necessary to verify the accuracy of the financial reports
furnished by the audited Party or the amount of payments due by the audited
Party under this Agreement.  Any amounts shown to be owed but unpaid, or
overpaid and in need of reimbursement, shall be paid or refunded (as the case
may be) within thirty (30) days after the accountant’s report, plus interest (as
set forth in Section 8.12) from the original due date (unless challenged in good
faith by the audited Party in which case any dispute with respect thereto shall
be resolved in accordance with Article 14).  The auditing Party shall bear the
full cost of such audit unless such audit reveals an overcharge or underpayment
by the audited Party that resulted from a discrepancy in a report that the
audited Party provided to the other Party during the applicable audit period,
which underpayment or overcharge was more than five percent (5%) of the amount
set forth in such report, in which case the audited Party shall bear the full
cost of such audit.

(c)Audit Dispute.  In the event of a dispute with respect to any audit under
Section 8.13(b), FibroGen and AstraZeneca shall work in good faith to resolve
the disagreement.  If the Parties are unable to reach a mutually acceptable
resolution of any such dispute within thirty (30) days, the dispute shall be
submitted for resolution to an independent certified public accounting firm
jointly selected by each Party’s certified public accountants or to such other
entity or individual as the Parties shall mutually agree (the “Auditor”).  The
decision of the Auditor shall be final and the costs of such resolution as well
as the initial audit shall be borne between the Parties in such manner as the
Auditor shall determine.  Not later than ten (10) days after such decision and
in accordance with such decision, the audited Party shall pay the additional
amounts, with interest from the date originally due as provided in Section 8.12
or the auditing Party shall reimburse the excess payments, as applicable.

8.14Manner and Place of Payment.  All payments owed under this Agreement shall
be made by wire transfer in immediately available funds to a bank and account
designated in writing by FibroGen or AstraZeneca (as applicable), unless
otherwise specified in writing by such Party. All payments hereunder shall be
invoiced by the Payee to the Payor. Each invoice to AstraZeneca shall fulfill
the requirements set forth on Exhibit L.

8.15Estimated Sales and Accruals.  To the extent Net Sales are based on
quarterly estimates or accruals for anticipated sales of Products in the
Territory, AstraZeneca shall notify FibroGen of any such estimates or accruals
or adjustments or changes based on a revision in estimates and accruals within
thirty (30) days of each Calendar Quarter in order to allow FibroGen to timely
meet any then applicable public reporting requirements of FibroGen with respect
to sales and royalties to FibroGen for Products.

ARTICLE 9

Intellectual Property

9.1Intellectual Property Committee.  The Parties shall, promptly after the
Effective Date, establish an intellectual property committee (the “IP
Committee”) comprised of at least one senior patent attorney from each Party,
together with other representatives of the Parties as the

65.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Parties may determine to be appropriate from time to time, to review and
discuss, in each case with respect to FibroGen Patents and Joint Patents, the
patent prosecution strategy (including whether and where to file patent
applications), Orange Book Listings, applications for patent term extension and
notices of infringement, as well as the selection, registration, maintenance and
defense of Marks and interest in Third Party intellectual property.  The IP
Committee will serve solely an advisory purpose and shall not have authority to
approve or disapprove any actions with respect to patent filing, prosecution and
maintenance under this Agreement.

9.2Ownership of Inventions.  Ownership of Information and inventions, whether or
not patentable, made during the Term in the course of conducting activities
under this Agreement, including all intellectual property rights therein
(collectively, “Inventions”) shall be as follows: (a) FibroGen shall own all
Inventions [ * ], whether made solely by employees, agents or independent
contractors of either Party or its respective Affiliates, or jointly by
employees, agents or independent contractors of both Parties or their respective
Affiliates (collectively, “Collaboration Inventions”), (b) AstraZeneca shall own
all Inventions that are made solely by employees, agents or independent
contractors of AstraZeneca or its Affiliates that are not Collaboration
Inventions, (c) FibroGen shall own all Inventions that are made solely by
employees, agents or independent contractors of FibroGen or its Affiliates that
are not Collaboration Inventions, and (d) the Parties shall jointly own all
Inventions that are made jointly by employees, agents, or independent
contractors of each Party or its Affiliates that are not Collaboration
Inventions (“Joint Inventions”).  Except to the extent either Party is
restricted by the licenses granted to the other Party under this Agreement, each
Party shall be entitled to practice, grant licenses to, assign and exploit the
Joint Inventions and Patents claiming Joint Inventions (“Joint Patents”) without
the duty of accounting or seeking consent from the other Party. AstraZeneca
hereby assigns to FibroGen all of its and its Affiliates’ right, title and
interest in and to the Collaboration Inventions, and agrees to take such further
actions reasonably requested by FibroGen to evidence such assignment, except
where such Collaboration Inventions have been made by an independent contractor
retained by AstraZeneca without such contractor having agreed to assign such
Collaboration Inventions to AstraZeneca, as approved by the JDC.

9.3Disclosure of Inventions.  Each Party shall promptly disclose to the other
all Inventions promptly after becoming aware of them, including all invention
disclosures or other similar documents submitted to such Party by its, or its
Affiliates’, employees, agents or independent contractors describing such
Inventions.  Such Party shall also respond promptly to reasonable requests from
the other Party for more Information relating to such Inventions.

9.4Prosecution of Patents.

(a)FibroGen Patents.  Except as otherwise provided in this Section 9.4(a), as
between the Parties, FibroGen shall have the sole right and authority to manage
all FibroGen Patent prosecution activities under this Agreement, at its sole
expense.  This includes the right and authority to prepare, file, prosecute and
maintain all FibroGen Patents in any jurisdiction in the world, including
defending such FibroGen Patents in any patent office proceedings, pre- or
post-grant or issuance, including reissue, reexamination, limitation or
invalidation proceedings, or any opposition- or interference-type proceeding or
challenge.  FibroGen shall provide AstraZeneca

66.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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reasonable opportunity to review and comment on filing and prosecution efforts
regarding the FibroGen Patents in the Territory.  FibroGen shall, if requested
by AstraZeneca, provide AstraZeneca with copies of material communications from
any patent authority in the Territory regarding any FibroGen Patents, and shall
if requested provide drafts of any material filings or material responses to be
made to such patent authorities a reasonable amount of time in advance of
submitting such filings or responses so that AstraZeneca may have the
opportunity to review and comment thereon.  FibroGen shall further take into
account and may include, at FibroGen’s sole discretion, any reasonable comments
provided by AstraZeneca prior to submission of any such filings or responses.

(b)Requested Filings.  If AstraZeneca desires FibroGen to file, in a particular
jurisdiction in the Territory, a FibroGen Patent that claims priority to (or is
based on the subject matter of) another FibroGen Patent, or that claims a
Collaboration Invention, AstraZeneca shall provide written notice to FibroGen
requesting that FibroGen file such patent application in such jurisdiction.  If
AstraZeneca provides such written notice to FibroGen, FibroGen shall file and
prosecute such patent application and maintain any patent issuing thereon in
such jurisdiction; provided that FibroGen shall not be obligated to conduct any
such activities (including filing a patent application) that FibroGen reasonably
believes may have an adverse effect on the FibroGen Patents anywhere in the
Territory.

(c)Joint Patents.  With respect to any potentially patentable Joint Invention,
AstraZeneca shall have the first right, but not the obligation, to prepare
patent applications based on such Joint Invention, to file and prosecute
(including defense of any oppositions, interferences, reissue proceedings and
reexaminations) such patent applications, and to maintain any Joint Patents
issuing therefrom, in any jurisdictions throughout the Territory.  FibroGen
shall have the corresponding first right, but not the obligation, in any
jurisdictions outside of the Territory other than China, in respect of which the
China Agreement shall govern. If AstraZeneca determines in its sole discretion
to abandon, cease prosecution or otherwise not file or maintain any Joint Patent
anywhere in the Territory, then AstraZeneca shall provide FibroGen written
notice of such determination at least thirty (30) days before any deadline for
taking action to avoid abandonment (or other loss of rights) and shall provide
FibroGen with the opportunity to prepare, file, prosecute and maintain such
Joint Patent.  The Party that is responsible for preparing, filing, prosecuting,
and maintaining a particular Joint Patent (the “Prosecuting Party”) shall
provide the other Party reasonable opportunity to review and comment on such
prosecution efforts regarding such Joint Patent, and such other Party shall
provide the Prosecuting Party reasonable assistance in such efforts.  The
Prosecuting Party shall provide the other Party with a copy of all material
communications from any patent authority in the applicable jurisdictions
regarding the Joint Patent being prosecuted by such Party, and shall provide
drafts of any material filings or responses to be made to such patent
authorities a reasonable amount of time in advance of submitting such filings or
responses.  In particular, each Party agrees to provide the other Party with all
information necessary or desirable to enable the other Party to comply with the
duty of candor/duty of disclosure requirements of any patent authority.  Either
Party may determine that it is no longer interested in supporting the continued
prosecution or maintenance of a particular Joint Patent in a country or
jurisdiction, in which case:  (i) the disclaiming Party shall, if requested in
writing by the other Party, assign its ownership interest in such Joint Patent
in such country or jurisdiction to

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the other Party for no additional consideration; and (ii) if such assignment is
effected, any such Joint Patent would thereafter be deemed a FibroGen Patent in
the case of assignment to FibroGen, or a AstraZeneca Patent in the case of
assignment to AstraZeneca; provided, however, that the disclaiming party would
have an immunity from suit under such FibroGen Patent or AstraZeneca Patent, as
the case may be, in the applicable country or jurisdiction.  In addition, any
Joint Patent that becomes a FibroGen Patent pursuant to the preceding sentence
shall be excluded from the license granted to AstraZeneca in Section 7.1.  Each
Party shall bear its own internal costs in respect of the prosecution of Joint
Patents.  Out-of-pocket costs incurred in respect of the prosecution and
maintenance of Joint Patents in the Territory shall be borne equally by
AstraZeneca and FibroGen.  In the event a Party elects to disclaim its interest
in a Joint Patent, the costs incurred with respect to such Patent after the date
of such disclaimer shall thereafter be borne exclusively by the other Party,
without reimbursement or credit.

(d)Cooperation in Prosecution.  Each Party shall, through the IP Committee,
provide the other Party all reasonable assistance and cooperation in the Patent
prosecution efforts provided above in this Section 9.4, including providing any
necessary powers of attorney and executing any other required documents or
instruments for such prosecution.

9.5Infringement of FibroGen Patents by Third Parties.

(a)Notification.

(i)Within five (5) Business Days from (A) a Party’s or its Affiliate’s receipt
of any notice of any certification filed under the U.S. “Drug Price Competition
and Patent Term Restoration Act” of 1984 as amended or supplemented or any
successor law or (B) a Party’s or its Affiliate’s receipt of any notice of any
certification filed under Section 505(j) of the FD&C Act or an application under
Section 505(b)(2) of the FD&C Act naming a Product as a reference listed drug
and including a certification under Section 505(j)(2)(A)(vii)(IV) or
505(b)(2)(A)(iv), respectively or (C) any equivalent proceeding in any country
in RoW (each of (A), (B) and (C), a “Product Infringement”) such Party shall
notify the other Party thereof in writing.

(ii)If there is any infringement, threatened infringement, imminent infringement
or alleged infringement of any FibroGen Patent on account of a Third Party’s
manufacture, use, offer for sale, or sale of a Collaboration Compound or Product
in the Territory not within Section 9.5(a)(i) (“Other Infringement”) then each
Party shall promptly notify the other Party in writing of any such Other
Infringement of which it becomes aware, and shall provide evidence in such
Party’s possession demonstrating such Other Infringement.

(b)Enforcement Rights.

(i)RoW Litigation.  AstraZeneca shall have the first right, but not the
obligation, to bring an appropriate suit or other action against any person or
entity allegedly engaged in any Product Infringement or Other Infringement of
the FibroGen Patents in the RoW (and to defend any related counterclaim), at
AstraZeneca’s expense. AstraZeneca shall have a period of one hundred eighty
(180) days after its receipt or delivery of notice and evidence pursuant to
Section 9.5(a)(i), to elect to so enforce such FibroGen Patent in the RoW (or to
settle in

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accordance with Section 9.5(c) or otherwise secure the abatement of such Product
Infringement or Other Infringement).  In the event AstraZeneca does not so elect
(or settle or otherwise secure the abatement of such Product Infringement or
Other Infringement), it shall so notify FibroGen in writing as soon as
practicable following the decision and in any event within such one hundred
eighty (180)-day period, and FibroGen shall have the right to commence a suit or
take action to enforce the applicable FibroGen Patents with respect to such
Product Infringement or Other Infringement in the RoW (and to defend any related
counterclaim) at FibroGen’s expense. The IP Committee shall take the necessary
actions to ensure that AstraZeneca has proper standing to bring suit under this
Section 9.5(b)(i).

(ii)U.S. Litigation. AstraZeneca shall have the first right, but not the
obligation, to bring an appropriate suit or other action against any person or
entity allegedly engaged in any Product Infringement or Other Infringement of
the FibroGen Patents in the U.S. (and to defend any related counterclaim), at
AstraZeneca’s expense. AstraZeneca shall have a period of thirty (30) days, with
respect to a Product Infringement, and one hundred eighty (180) days with
respect to an Other Infringement, after its receipt or delivery of notice and
evidence pursuant to Section 9.5(a)(i), to elect to so enforce such FibroGen
Patent in the U.S. (or to settle in accordance with Section 9.5(c) or otherwise
secure the abatement of such Product Infringement or Other Infringement). The
Parties shall meet periodically to discuss in good faith and determine an
enforcement strategy, and AstraZeneca shall act consistently with any such
agreed strategy. In the event AstraZeneca does not so elect (or settle or
otherwise secure the abatement of such Product Infringement or Other
Infringement), it shall so notify FibroGen in writing as soon as practicable
following the decision and in any event within such thirty (30)- or one hundred
eighty (180)-day period, as applicable, and FibroGen shall have the right to
commence a suit or take action to enforce the applicable FibroGen Patents with
respect to such Product Infringement or Other Infringement in the U.S. (and to
defend any related counterclaim), at FibroGen’s expense. The IP Committee shall
take the necessary actions to ensure that AstraZeneca has proper standing to
bring suit under this Section 9.5(b)(ii).

(iii)Cooperation.  In any action, suit or proceeding instituted under this
Section 9.5(b), the Parties shall cooperate with and assist each other in all
reasonable respects.  Upon the reasonable request of the Party instituting such
action, suit or proceeding, the other Party shall join such action, suit or
proceeding and shall be represented using counsel of its own choice, at the
requesting Party’s expense.  If a Party with the right to initiate legal
proceedings under this Section 9.5(b) lacks standing to do so and the other
Party has standing to initiate such legal proceedings, then the Party with
standing shall initiate such legal proceedings at the request and expense of the
other Party (including reasonable internal personnel costs at the Hourly Rate).

(c)Settlement.  Without the prior written consent of the other Party, neither
Party shall settle any claim, suit or action that it brought under Section
9.5(b) involving FibroGen Patents in any manner that would negatively impact
such intellectual property or that would limit or restrict the ability of either
Party to sell Products anywhere in or outside the Territory.

(d)Recoveries.  If either Party recovers monetary damages from a Third Party in
a suit or action in respect of a Product Infringement or Other Infringement,
such recovery shall

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be allocated first to the reimbursement of any expenses incurred by the Parties
in such litigation and any remaining amount shall be deemed Net Sales and
retained by (or paid to) AstraZeneca, subject to royalty payments on such deemed
Net Sales pursuant to Section 8.6.

(e)Designated Products.  Notwithstanding anything to the contrary in this
Agreement:

(i)FibroGen shall have the sole right to enforce the FibroGen Patents against
any of the Designated Products (“Designated Product Infringement”), and
AstraZeneca shall be solely responsible for all expenses reasonably incurred in
connection therewith and subject further to (ii) below.  FibroGen will invoice
AstraZeneca for its share of such expenses on a Calendar Quarter basis
(including its internal personnel costs at the Hourly Rate), and AstraZeneca
will pay each such invoice within forty-five (45) days after receipt thereof.

(ii)Notwithstanding (i) above, (A) in no event shall [ * ]; provided that in
Calendar Years 2018, 2019 and 2020, AstraZeneca shall not be obligated to [ * ],
except that if AstraZeneca reimburses [ * ] (the “Deficit”), the [ * ] (see
example below); (B) in enforcing the FibroGen Patents against any of the
Designated Products, the Parties shall unanimously select outside counsel to
represent FibroGen in such enforcement proceedings (failing such unanimous
agreement AstraZeneca shall be [ * ] (C) FibroGen shall, at all times, keep
AstraZeneca reasonably informed regarding such enforcement proceedings and shall
take into account any good faith comments made by AstraZeneca relating to such
enforcement proceedings; and (D) FibroGen shall provide AstraZeneca with
reasonably sufficient information regarding such enforcement proceedings to
demonstrate that any such proceedings have a good faith basis and are brought
and maintained in good faith.  By way of example of clause (A), [ * ].

(f)Non-Product-Related Infringements.  As between the Parties, FibroGen shall
have the sole right to enforce the FibroGen Patents in the Territory against any
infringement, imminent infringement, threatened infringement or alleged
infringement that is not a Product Infringement, a Designated Product
Infringement or an Other Infringement, at its expense, and to retain all
associated recoveries; provided that in no event will FibroGen place an Orange
Book-listed FibroGen Patent (or a FibroGen Patent listed on a Form 3542
submitted in accordance with Section 9.12 upon or after approval of the NDA as a
timely filed patent) into litigation without AstraZeneca’s prior written
approval, which approval will not be unreasonably withheld.

(g)Joint Patents.  Each Party shall promptly notify the other Party upon
becoming aware of any infringement, imminent infringement, threatened
infringement or alleged infringement of any Joint Patent (“Joint Patent
Infringement”).  The Parties will promptly thereafter meet to discuss in good
faith how and whether to proceed to enforce the applicable Joint Patent against
such Joint Patent Infringement.  If the Parties fail to agree within sixty (60)
days, then either Party shall have the right to take any action permitted under
applicable law.

(h)Patents Licensed from Third Parties. Each Party’s rights under this Section
9.5 with respect to any FibroGen Patent licensed from a Third Party shall be
subject to the

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rights of such Third Party to enforce such FibroGen Patent and/or defend against
any claims that such FibroGen Patent is invalid or unenforceable.

9.6Defense of FibroGen Patents.  To the extent any Party receives notice by
counterclaim, or otherwise, alleging the invalidity or unenforceability of any
FibroGen Patent in the Territory, it shall bring such fact to the attention of
the other Party, including all relevant information related to such claim.  The
Parties, through the JSC, shall discuss such claim.  Where such allegation is
made within the context of a patent office proceeding, the provisions of Section
9.4 shall apply.  Where such allegation is made in a counterclaim to or in
connection with a suit or other action brought under Section 9.5, the provisions
of Section 9.5 shall apply.  In all other cases, (a) where such action relates
to a FibroGen Patent in the U.S., FibroGen shall have the first right to defend
such action, at FibroGen’s expense, and AstraZeneca will cooperate with
FibroGen, at FibroGen’s expense, in such defense, and (b) where such action
relates to a FibroGen Patent within the RoW, AstraZeneca shall have the first
right but not the obligation to defend such action, at AstraZeneca’s expense,
and FibroGen will cooperate with AstraZeneca, at AstraZeneca’s expense, in such
defense.  In the event a Party does not so elect to exercise its first right to
defend an action under this Section 9.6, it shall so notify the other Party in
writing, and such other Party shall have the right to so defend such action at
its expense.  Each Party shall provide to the Party defending any such rights
under this Section 9.6 all reasonable assistance in such enforcement, at such
defending Party’s request and expense.  The defending Party shall keep the other
Party regularly informed of the status and progress of such efforts, and shall
reasonably consider the other Party’s comments on any such efforts.

9.7Third Party Patents.  FibroGen shall have the sole right and authority to
initiate and/or pursue at its sole expense any patent office proceeding, pre- or
post-grant or issuance, including reissue, reexamination, limitation, or
invalidation proceedings, or any opposition- or interference-type proceeding or
challenge against any Third Party Patent that relates or that may potentially
relate to the manufacture, use, or sale of a HIF Compound, a Product, or a
Designated Product.

9.8Defense of Infringement Actions.  During the Term, each Party shall bring to
the attention of the other Party all information regarding potential
infringement or any claim of infringement of Third Party intellectual property
rights in connection with the development, manufacture, production, use,
importation, offer for sale, or sale of Products in the Territory.  Subject to
Article 11, each Party shall be solely responsible at its sole expense for
defending any action, suit, or other proceeding brought against it alleging
infringement of Third Party intellectual property rights in connection with its
activities under this Agreement.  This Section 9.8 shall not be interpreted as
placing on either Party a duty of inquiry regarding Third Party intellectual
property rights.

9.9Patent Marking.  AstraZeneca shall, and shall require its Affiliates and
Sublicensees to, mark Products sold by it hereunder (in a reasonable manner
consistent with industry custom and practice) with appropriate patent numbers or
indicia to the extent permitted by applicable law and regulations, in those
countries in which such markings or such notices impact recoveries of damages or
equitable remedies available with respect to infringements of

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patents.  The Parties agree that listing the appropriate Patent(s) in the Orange
Book shall be deemed a marking in a reasonable manner consistent with industry
custom and practice under this Section 9.9, and FibroGen agrees to use good
faith efforts to obtain, as soon as reasonably practicable after the Effective
Date, a written confirmation from DFCI that DFCI so agrees.

9.10Personnel Obligations. Prior to beginning work under this Agreement relating
to any research, Development or Commercialization of a Collaboration Compound or
a Product, to HIF or in the Field, each employee, agent or independent
contractor of AstraZeneca or FibroGen or of either Party’s respective Affiliates
shall be bound by non-disclosure and invention assignment obligations which are
consistent with the obligations of AstraZeneca or FibroGen, as appropriate, in
this Article 9, including without limitation: (a) promptly reporting any
invention, discovery, process or other intellectual property right; (b)
assigning to AstraZeneca or FibroGen, as appropriate, all of his or her right,
title and interest in and to any invention, discovery, process or other
intellectual property right, such that AstraZeneca or FibroGen, as appropriate,
can then comply with its obligations under this Agreement with respect to such
invention, discovery, process or other intellectual property right; (c)
cooperating in the preparation, filing, prosecution, maintenance and enforcement
of any patent and patent application; (d) performing all acts and signing,
executing, acknowledging and delivering any and all documents required for
effecting the obligations and purposes of this Agreement; and (e) abiding by the
obligations of confidentiality and non-use set forth in Article 12.  It is
understood and agreed that such non-disclosure and invention assignment
agreement need not reference or be specific to this Agreement.

9.11Trademarks.  The Parties shall use Commercially Reasonable Efforts to
develop a worldwide trademark, and if not possible, trademark for the Territory
consistent with the trademarks for Products selected under the Astellas
Collaboration. AstraZeneca, following discussion with FibroGen, shall be
responsible for the selection, registration, ownership, maintenance and defense
of all trademarks for use in connection with the sale or marketing of Products
in the Field in the Territory (the “Marks”), as well as all expenses associated
therewith.  All uses of the Marks shall be reviewed by the JCC and shall comply
with all applicable laws and regulations (including those laws and regulations
particularly applying to the proper use and designation of trademarks in the
applicable countries).  Neither Party shall, without the other Party’s prior
written consent, use any trademarks or house marks of the other Party (including
the other Party’s corporate name), or marks confusingly similar thereto, in
connection with such Party’s marketing or promotion of Products under this
Agreement, except as may be expressly authorized in connection with activities
under Article 5 and except to the extent required to comply with applicable laws
and regulations. During the Term, AstraZeneca grants to FibroGen the
non-exclusive right, free of charge, to use the AstraZeneca name and logo in the
U.S. solely for the purpose of Commercializing the Products in accordance with
the terms of this Agreement, the U.S. Commercialization Plan and the
Co-Commercialization Agreement, and FibroGen grants to AstraZeneca the
non-exclusive right, free of charge, to use the FibroGen name and logo in the
U.S. solely for the purpose of Commercializing the Products in accordance with
the terms of this Agreement, provided that such rights shall be exercised, and
all Products bearing such names and/or logos shall be manufactured, in
accordance with the quality standards for such logos and trademarks established
by the JSC. AstraZeneca shall remain the owner of the AstraZeneca name

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and logo and the trademarks and the goodwill pertaining thereto.  FibroGen shall
remain the owner of the FibroGen name and logo and the trademarks and the
goodwill pertaining thereto.

9.12Listing.  Prior to the submission of the first NDA of a Product in the U.S.,
the Parties shall discuss in good faith in the IP Committee the Orange Book
listings. FibroGen shall be responsible for the submission of documents
associated with Orange Book listings in accordance with the plan set forth by
the IP Committee. Upon FibroGen’s receipt of a notice of allowance (or
equivalent) of an applicable FibroGen Patent, FibroGen shall promptly provide
AstraZeneca notification of such allowance and the Parties shall discuss in good
faith in the IP Committee whether to list such FibroGen Patent in the Orange
Book maintained by the FDA or similar or equivalent patent listing source, if
any, in other countries in the Territory.  FibroGen shall cooperate with
AstraZeneca’s reasonable requests in connection therewith, including meeting any
submission deadlines.

9.13Patent Term Extension.  AstraZeneca shall be responsible for and control,
but shall confer with FibroGen in, the selection of the appropriate FibroGen
Patents as listed in the patent information section of the NDA or MAA for
Products for filing to obtain a Patent Term Extension pursuant to all applicable
laws, including without limitation any other extensions that are now or become
available in the future wherever applicable to such patents that are applicable
to the Products; provided, however, that AstraZeneca shall not have the right to
make any such filing with respect to any FibroGen Patent that is not set forth
on Exhibit M without the prior written consent of FibroGen.

ARTICLE 10

Representations And Warranties

10.1Mutual Representations and Warranties.  Each Party hereby represents,
warrants, and covenants (as applicable) to the other Party as follows, as of the
Effective Date:

(a)Corporate Existence and Power.  It is a company or corporation duly
organized, validly existing, and in good standing under the laws of the
jurisdiction in which it is incorporated, and has full corporate power and
authority and the legal right to own and operate its property and assets and to
carry on its business as it is now being conducted and as contemplated in this
Agreement, including, without limitation, the right to grant the licenses
granted by it hereunder.

(b)Authority and Binding Agreement.  (i) It has the corporate power and
authority and the legal right to enter into this Agreement and perform its
obligations hereunder; (ii) it has taken all necessary corporate action on its
part required to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder; and (iii) this Agreement has been duly
executed and delivered on behalf of such Party, and constitutes a legal, valid,
and binding obligation of such Party that is enforceable against it in
accordance with its terms.

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(c)No Conflict.  It is not a party to and will not enter into any agreement that
would prevent it from granting the rights granted to the other Party under this
Agreement or performing its obligations under this Agreement.

(d)No Debarment.  In the course of the Development of Products, such Party has
not used prior to the Effective Date and shall not use, during the Term, any
employee, agent or independent contractor who has been debarred by any
Regulatory Authority, or, to the best of such Party’s knowledge, is the subject
of debarment proceedings by a Regulatory Authority.

10.2Representations and Warranties by FibroGen.  FibroGen hereby represents and
warrants to AstraZeneca, as of the Effective Date, as follows:

(a)Title; Encumbrances.  Except for the Patents licensed to FibroGen under the
DFCI Agreement and the Information licensed to FibroGen under the Astellas
Agreements, FibroGen is the sole and exclusive owner of the entire right, title
and interest in (a) the Listed Patents and (b) the FibroGen Know-How existing as
of the Effective Date. FibroGen has all rights necessary to grant the licenses
under the FibroGen Technology that it grants to AstraZeneca under this
Agreement.  Neither the Listed Patents nor the FibroGen Know-How is subject to
any mortgage, pledge, lien, security interest, conditional and installment sale
agreements, encumbrance or charges or claims of any kind.

(b)No Other Patents than those Listed. The Listed Patents represent all Patents
that, as of the Effective Date, are Controlled by FibroGen and which, to
FibroGen’s knowledge, cover or claim any invention necessary or useful for the
Development or Commercialization of Collaboration Compounds or Products in the
Field in the Territory as contemplated as of the Effective Date.

(c)Prosecution of Patents etc.  To FibroGen’s knowledge, the Listed Patents are
being diligently prosecuted before the respective patent authorities in
accordance with applicable law.  All applicable fees due to patent authorities
with respect to the filing and prosecution of the Listed Patents existing as of
the Effective Date have been paid on or before the due date for payment (as such
due date may be extended in accordance with applicable laws or patent authority
rules and regulations).  FibroGen has not received any written notice alleging
that the Listed Patents existing as of the Effective Date, if issued, would be
invalid or unenforceable or that the Patent applications included in such Listed
Patents will not proceed to grant.  To FibroGen’s knowledge, in respect of any
pending U.S. patent applications included in the Listed Patents, FibroGen has
submitted all material prior art of which it is aware in accordance with the
requirements of the United States Patent and Trademark Office.  To its
knowledge, FibroGen has properly identified each and every inventor of the
claims of the Listed Patents existing as of the Effective Date.

(d)No Infringement or Misappropriation.  FibroGen has not received any written
notice from any Third Party asserting or alleging that any research or
development of Collaboration Compounds or Products by FibroGen or by Astellas
prior to the Effective Date infringed or misappropriated the intellectual
property rights of such Third Party and FibroGen has

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no reason to suspect that any such infringement or misappropriation has
occurred.  To FibroGen’s knowledge, the conception, development and reduction to
practice of the Listed Patents and FibroGen Know-How existing as of the
Effective Date have not constituted or involved the misappropriation of trade
secrets or other proprietary rights of any person or entity.

(e)Non-infringement of Third Party Rights.  To FibroGen’s knowledge, the
research, development, manufacture, use and sale after the Effective Date of
FG-4592 in the CKD Indications can be carried out in the manner reasonably
contemplated as of the Effective Date without infringing any published patent
applications or patents owned or controlled by a Third Party.

(f)No Proceedings.  There are no pending actions, suits or proceedings against
FibroGen or any of its Affiliates involving the FibroGen Technology,
Collaboration Compounds or Products.

(g)Third Party Activities.  To FibroGen’s knowledge, except as disclosed in a
writing of even date herewith by FibroGen to AstraZeneca, there are no
activities by Third Parties that would constitute infringement or
misappropriation of the FibroGen Technology (in the case of pending claims,
evaluating them as if issued).

(h)DFCI Agreement.  The DFCI Agreement is in full force and effect. FibroGen has
no cause to believe that the DFCI Agreement is likely to be terminated prior to
its expiry. To FibroGen’s knowledge, neither DFCI nor FibroGen is in breach of
any of its obligations under the DFCI Agreement.  [ * ].

(i)Astellas Agreements. Nothing in the Astellas Agreements prevents FibroGen
from granting the rights to AstraZeneca granted under this Agreement or prevents
either FibroGen or AstraZeneca from exercising their rights or performing their
obligations under this Agreement.

(j)Documentation Made Available to AstraZeneca.  FibroGen has made available to
AstraZeneca all material Regulatory Material, FibroGen Know-How and other
Information in its possession or Control regarding or related to any
Collaboration Compound and Product. All Regulatory Material, FibroGen Know-How
and other Information in FibroGen’s possession and Control provided to
AstraZeneca regarding or related to any Collaboration Compound or Product are,
to FibroGen’s knowledge, true, complete and correct in all material
respects.  As of the Effective Date, FibroGen has prepared, maintained and
retained in all material respects all material Regulatory Material that FibroGen
is required to maintain or report pursuant to and in accordance with GLP, GCP,
regulations and other applicable law.

(k)Patent Litigation.  Neither FibroGen nor its Affiliates will initiate or
maintain any patent enforcement proceeding or litigation with respect to any
Designated Product unless it has a good faith basis for doing so.

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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10.3Anti-Bribery and Anti-Corruption Compliance.

(a)Each Party agrees, on behalf of itself, its officers, directors and employees
and on behalf of its Affiliates, agents, representatives, consultants and
subcontractors hired in connection with the subject matter of this Agreement
(together with such Party, the “Representatives”) that for the performance of
its obligations hereunder:

(i)The Representatives shall not directly or indirectly pay, offer or promise to
pay, authorize the payment of any money or give, offer or promise to give, or
authorize the giving of anything else of value, to: (a) any Government Official
in order to influence official action; (b) any individual or entity (whether or
not a Government Official) (1) to influence such individual or entity to act in
breach of a duty of good faith, impartiality or trust (“acting improperly”), (2)
to reward such individual or entity for acting improperly or (3) where such
individual or entity would be acting improperly by receiving the money or other
thing of value; (c) any individual or entity (whether or not a Government
Official) while knowing or having reason to know that all or any portion of the
money or other thing of value will be paid, offered, promised or given to, or
will otherwise benefit, a Government Official in order to influence official
action for or against either Party in connection with the matters that are the
subject of this Agreement; or (d) any individual or entity (whether or not a
Government Official) to reward that individual or entity for acting improperly
or to induce that individual or entity to act improperly.

(ii)The 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.

(b)The Representatives shall comply with the Anti-Corruption Laws plus the
AstraZeneca Anti-Corruption Rules and Policies and shall not take any action
that will, or would reasonably be expected to, cause either Party or its
Affiliates to be in violation of any such laws or policies.

(c)Each Party, on behalf of itself and its other Representatives, represents and
warrants to the other Party that to the best of such Party’s and its Affiliates’
knowledge, no Representative that will participate or support its performance of
its obligations hereunder has, directly or indirectly, (i) paid, offered or
promised to pay or authorized the payment of any money, (ii) given, offered or
promised to give or authorized the giving of anything else of value or (iii)
solicited, received or agreed to accept any payment of money or anything else of
value, in each case ((i), (ii) and (iii)), in violation of the Anti-Corruption
Laws during the three (3) years preceding the date of this Agreement.

(d)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 such
Party or its Representative of any representation, warranty or undertaking set
forth in Sections 10.3(a)-(c); or (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 the Representatives connected with this Agreement that any of them is

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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the target of a formal investigation by a governmental authority for a Material
Anti-Corruption Law Violation.

(e)Without prejudice to any auditing or inspection rights set forth elsewhere in
this Agreement, each Party shall for the term of this Agreement and six (6)
years thereafter, for the purpose of allowing the other Party to audit and
monitor the performance of its compliance with this Agreement and particularly
this Section 10.3 permit the other Party, its Affiliates, any auditors of any of
them and any governmental authority to have reasonable access to any premises of
such Party or other Representatives used in connection with this Agreement,
together with a right to reasonably access personnel and records that relate to
this Agreement (“Compliance Audit”). The results of any such audit shall
constitute Confidential Information of the audited Party, in respect of which
the other Party shall comply with the provisions contained in Article 12
(subject to the terms and exceptions set forth therein or in this Section 10.3).

(i)To the extent that any Compliance Audit by a Party requires access and review
of any commercially or strategically sensitive information of the other Party or
any of its other Representatives relating to the business of such Party or any
other Representatives (including information about prices and pricing policies,
cost structures and business strategies), such activity shall be carried out by
a Third Party professional advisor appointed by the other Party and such
professional advisors shall only report back to the other Party such information
as is directly relevant to informing the other Party on such Party’s compliance
with the particular provisions of the Agreement being Compliance Audited.

(ii)Each Party shall, and shall cause its Representatives to, provide all
cooperation and assistance during normal working hours as reasonably requested
by the other Party for the purposes of a Compliance Audit.  Such other Party
shall ensure that any Third Party auditor enters into a confidentiality
agreement consistent with applicable requirements of Article 12 hereof in all
material respects.  Such other Party shall instruct any Third Party auditor or
other Person given access in respect of a Compliance Audit to cause the minimum
amount of disruption to the business of the audited Party and its Affiliates and
to comply with relevant building and security regulations.

(iii)The costs and fees of any Compliance Audit shall be paid by the auditing
Party, except that if an inspection or Compliance Audit reveals any breach or
violation by the audited Party (including through its other Representatives) of
any representation, warranty or undertaking set forth in Sections 10.3(a)-(c),
the costs of such inspection or Compliance Audit shall be paid by the audited
Party.  The audited Party shall bear its own costs of rendering assistance to
the Compliance Audit.

(f)On the occurrence of any of the following events:  (A) A Party becomes aware
of, whether or not through a Compliance Audit, that the other Party (or any
other Representative) is in breach or violation of any representation, warranty
or undertaking in Sections 10.3(a)-(c) or of the Anti-Corruption Laws; or (B)
notification is received under Section 10.3(d) relating to any suspected or
actual Material Anti-Corruption Law Violation by a Party or its Representative,
in either case ((A) or (B)), the other Party shall have the right, in addition
to any

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other rights or remedies under this Agreement or to which such other Party may
be entitled in law or equity, to (x) take such steps as are reasonably necessary
in order to avoid a potential violation or continuing violation by such other
Party or any of its Affiliates of the Anti-Corruption Laws, including by
requiring that the Party agrees to such additional measures, representations,
warranties, undertakings and other provisions as such other Party believes in
good faith are reasonably necessary (“Provisions”) and (y) terminate any or all
of the activities conducted by the Party pursuant to this Agreement or this
Agreement in its entirety, immediately in the event that:

(i)A Party refuses to agree to all of the Provisions required by the other Party
pursuant to this clause; provided that such other Party has (a) provided the
Party an explanation in reasonable detail as to why such other Party considers
such provisions necessary, (b) given the Party a reasonable opportunity to
review and comment on the proposed Provisions and to provide its view as to the
necessity or usefulness of these to address the event concerned and (c)
considered such comments in good faith, or

(ii)A Party reasonably concludes that there is no Provision available that would
enable such Party or its Affiliates to avoid a potential violation or continuing
violation of applicable Anti-Corruption Laws.

(g)Any termination of this Agreement pursuant to Section 10.3(f) shall be
treated as a termination for breach and the consequences of termination set
forth in Sections 13.6 and 13.7, as applicable, shall apply and
additionally:  (i) subject to the accrued rights of the Parties prior to
termination, the terminating Party shall have no liability to the other Party
for any fees, reimbursements or other compensation or for any loss, cost, claim
or damage resulting, directly or indirectly, from such termination; and (ii) any
amounts that would otherwise be payable with respect to such terminated
activities or pursuant to this Agreement in its entirety, as applicable,
including any then outstanding and unpaid claims for payment shall be null and
void to the extent permissible under applicable laws.

(h)Each Party shall be responsible for any breach of any representation,
warranty or undertaking in this Section 10.3 or of the Anti-Corruption Laws by
any of its Representatives.

(i)Each Party may disclose the terms of this Agreement or any action taken under
this Section 10.3 to prevent a potential violation or continuing violation of
applicable Anti-Corruption Laws, including the identity of the other Party and
the payment terms, to any Governmental Authority if such Party determines, upon
advice of counsel, that such disclosure is necessary.

(j)Each Party represents and warrants that (i) it has reviewed its internal
programs in relation to the Anti-Corruption Laws and the ability of the
Representatives to adhere to the AstraZeneca Anti-Corruption Rules and Policies
in performance of its obligations hereunder in advance of the signing of this
Agreement, (ii) it and the other Representatives can and will continue to comply
with such Anti-Corruption Laws and the AstraZeneca Anti-Corruption Rules and
Policies in performance of its obligations hereunder.  Should either Party
identify in writing

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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to the other Party any measures that should be reasonably taken to improve the
Representatives’ compliance with such Anti-Corruption Laws and the AstraZeneca
Anti-Corruption Rules and Policies for the performance of its obligations
hereunder (the “Improvement Plan”), the other Party shall implement such
Improvement Plan within an agreed reasonable timeframe (which shall in any event
not be in excess of three (3) calendar months) from the date the Improvement
Plan is delivered to the receiving Party or otherwise the requesting Party shall
be entitled to (x) terminate this Agreement, upon written notice to the other
Party with immediate effect, (y) be relieved of any obligations hereunder and
(z) seek compensation from the other Party.

10.4Disclaimer. Each Party understands that the Collaboration Compounds and
Products are the subject of ongoing clinical research and development and that
the other Party cannot assure the safety or usefulness of the Collaboration
Compounds or Products.  In addition, FibroGen makes no warranties except as set
forth in this Article 10 concerning the FibroGen Technology, and AstraZeneca
makes no warranties except as set forth in this Article 10 concerning the
AstraZeneca Technology.

10.5No Other Representations or Warranties.  EXCEPT AS EXPRESSLY STATED IN
SECTION 5.11 AND THIS ARTICLE 10, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER,
WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR
NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, IS MADE OR
GIVEN BY OR ON BEHALF OF A PARTY.  EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT,
ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR
OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

ARTICLE 11

Indemnification

11.1Indemnification by FibroGen.  FibroGen shall defend, indemnify, and hold
AstraZeneca, its Affiliates, and their respective officers, directors,
employees, and agents (the “AstraZeneca Indemnitees”) harmless from and against
any and all damages or other amounts payable to a Third Party claimant, as well
as any reasonable attorneys’ fees and costs of litigation incurred by such
AstraZeneca Indemnitees (collectively, “AstraZeneca Damages”), all to the extent
resulting from claims, suits, proceedings or causes of action brought by such
Third Party (“AstraZeneca Claims”) against such AstraZeneca Indemnitee that
arise from or are based on: (a) a breach of any of FibroGen’s representations,
warranties, and obligations under this Agreement; (b) the willful misconduct or
grossly negligent acts or omissions of FibroGen, its Affiliates, or the
officers, directors, employees, or agents of FibroGen or its Affiliates in the
performance of activities under this Agreement; (c) the research or Development
of Collaboration Compounds or Products by FibroGen before the Effective Date; or
(d) the Development, testing, manufacture, storage, handling, use, sale, offer
for sale, distribution and importation of Products by FibroGen or its Affiliates
or licensees (excluding, for clarity, AstraZeneca).  The foregoing indemnity
obligation shall not apply if the AstraZeneca Indemnitees materially fail to
comply with the

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indemnification procedures set forth in Section 11.3, or to the extent that such
AstraZeneca Claim is based on or alleges: (i) a breach of any of AstraZeneca’s
representations, warranties, and obligations under this Agreement; or (ii) the
willful misconduct or grossly negligent acts or omissions of AstraZeneca or its
Affiliates, or the officers, directors, employees, or agents of AstraZeneca or
its Affiliates in the performance of activities under this Agreement.

11.2Indemnification by AstraZeneca. AstraZeneca shall defend, indemnify, and
hold FibroGen, its Affiliates, and each of their respective officers, directors,
employees, and agents, (the “FibroGen Indemnitees”) harmless from and against
any and all damages or other amounts payable to a Third Party claimant, as well
as any reasonable attorneys’ fees and costs of litigation incurred by such
FibroGen Indemnitees (collectively, “FibroGen Damages”), all to the extent
resulting from any claims, suits, proceedings or causes of action brought by
such Third Party (collectively, “FibroGen Claims”) against such FibroGen
Indemnitee that arise from or are based on:  (a) the Development, testing,
manufacture, storage, handling, use, sale, offer for sale, distribution and
importation of Products by AstraZeneca or its Affiliates, Sublicensees, or
distributors; (b) a breach of any of AstraZeneca’s representations, warranties,
and obligations under the Agreement; or (c) the willful misconduct or grossly
negligent acts or omissions of AstraZeneca or its Affiliates, or the officers,
directors, employees, or agents of AstraZeneca or its Affiliates in the
performance of activities under this Agreement.  The foregoing indemnity
obligation shall not apply if the FibroGen Indemnitees materially fail to comply
with the indemnification procedures set forth in Section 11.3, or to the extent
that any FibroGen Claim is based on or alleges: (i) a breach of any of
FibroGen’s representations, warranties, and obligations under this Agreement; or
(ii) the willful misconduct or grossly negligent acts or omissions of FibroGen,
its Affiliates, or their officers, directors, employees, or agents in the
performance of activities under this Agreement.

11.3Indemnification Procedures.  The Party claiming indemnity under this Article
11 (the “Indemnified Party”) shall give written notice to the Party from whom
indemnity is being sought (the “Indemnifying Party”) promptly after learning of
the claim, suit, proceeding or cause of action for which indemnity is being
sought (“Claim”).  The Indemnified Party shall provide the Indemnifying Party
with reasonable assistance, at the Indemnifying Party’s expense, in connection
with the defense of the Claim for which indemnity is being sought.  The
Indemnified Party may participate in and monitor such defense with counsel of
its own choosing at its sole expense; provided, however, the Indemnifying Party
shall have the right to assume and conduct the defense of the Claim with counsel
of its choice.  The Indemnifying Party shall not settle any Claim without the
prior written consent of the Indemnified Party, not to be unreasonably withheld,
unless the settlement involves only the payment of money.  So long as the
Indemnifying Party is actively defending the Claim in good faith, the
Indemnified Party shall not settle any such Claim without the prior written
consent of the Indemnifying Party.  If the Indemnifying Party does not assume
and conduct the defense of the Claim as provided above, (a) the Indemnified
Party may defend against, and consent to the entry of any judgment or enter into
any settlement with respect to the Claim in any manner the Indemnified Party may
deem reasonably appropriate (and the Indemnified Party need not consult with, or
obtain any consent from, the Indemnifying Party in connection therewith), and
(b) the Indemnifying Party will remain responsible to indemnify the Indemnified
Party as provided in this Article 11.

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brackets, has been omitted because it is both (i) not material and (ii) would
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11.4Insurance. Each Party shall self-insure or procure and maintain insurance,
including product liability insurance, with respect to its activities hereunder
and which are consistent with normal business practices of prudent companies
similarly situated at all times during which any Product is being clinically
tested in human subjects or commercially distributed or sold until the
expiration or termination of this Agreement or four (4) years after termination
of any such clinical testing or commercial distribution, whichever is later.  It
is understood that such insurance shall not be construed to create a limit of
either Party’s liability with respect to its indemnification obligations under
this Article 11.  Each Party shall provide the other with written evidence of
such insurance upon request.  Each Party shall provide the other with written
notice at least thirty (30) days prior to the cancellation, non‑renewal or
material change in such insurance or self‑insurance which materially adversely
affects the rights of the other Party hereunder.

11.5DFCI Agreement.  [ * ]

ARTICLE 12

Confidentiality

12.1Product Information.  FibroGen recognizes that by reason of, among other
things, AstraZeneca’s status as licensee pursuant to the grants under Section
7.1, AstraZeneca has an interest in FibroGen’s retention in confidence of
information relating to the Collaboration Compounds or Products, and the
Development and Commercialization thereof.  Accordingly, during the Term,
FibroGen shall, and shall cause its Affiliates and their respective officers,
directors, employees and agents to, keep confidential, and not publish or
otherwise disclose, other than under written confidentiality and non-use terms,
and not use directly or indirectly for any purpose other than to perform
FibroGen’s obligations under this Agreement and the China Agreement, to conduct
research, Development and Commercialization of Products outside the Territory
pursuant to the Astellas Agreements or any Subsequent Agreement entered into
pursuant to Section 7.4(c), in connection with FibroGen’s research, development
and commercialization of other products, and as otherwise authorized under this
Agreement (including pursuant to Section 3.10), any (a) Regulatory Material
(including any Regulatory Approvals) with respect to any Collaboration Compound
or Product and (b) Information that is either Controlled by FibroGen or provided
to FibroGen pursuant to this Agreement relating to the Development or
Commercialization of Collaboration Compounds or Products, including development,
sales or marketing plans therefor (collectively, (a) and (b), “Product
Information”), except, in each case, to the extent (i) the Product Information
was generally available to the public or otherwise part of the public domain,
prior to the Effective Date, or thereafter became generally available to the
public or otherwise part of the public domain through no fault of FibroGen, its
Affiliates or any of their respective officers, directors, employees or agents
or (ii) the disclosure or use of such Product Information would be expressly
permitted under Section 12.3 or is otherwise expressly authorized under this
Agreement.  For clarification, the disclosure or transfer by FibroGen to
AstraZeneca or by AstraZeneca to FibroGen of any Product Information shall not
cause such information to cease to be subject to the provisions of this Section
12.1.  In the event this Agreement is terminated in its entirety or in a given
country for any reason, this Section 12.1 shall as from the effective date of
such termination have no continuing force or effect (provided that if such
termination is with

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brackets, has been omitted because it is both (i) not material and (ii) would
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respect to one or several specific country(ies) only, then this Section 12.1
will have no continuing force or effect as to such specific country(ies)) and
all Product Information shall be deemed to be Confidential Information of
FibroGen for purposes of the surviving provisions of this Agreement.  For
clarity, the foregoing shall not affect the Parties’ respective ownership of
Product Information.

12.2Confidentiality General.  Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing by the Parties, each Party agrees that,
during the Term and for ten (10) years thereafter, it shall keep confidential
and shall not publish or otherwise disclose and shall not use for any purpose
other than as provided for in this Agreement or the China Agreement (which
includes the exercise of any rights or the performance of any obligations
hereunder or thereunder) any Confidential Information furnished to it by the
other Party pursuant to this Agreement except for that portion of such
information or materials that the receiving Party can demonstrate by competent
written proof:

(a)was already known to the receiving Party or its Affiliate, other than under
an obligation of confidentiality, at the time of disclosure by the other Party;

(b)was generally available to the public or otherwise part of the public domain
at the time of its disclosure to the receiving Party;

(c)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;

(d)is subsequently disclosed to the receiving Party or its Affiliate by a Third
Party without obligations of confidentiality with respect thereto; or

(e)is independently discovered or developed by the receiving Party or its
Affiliate without the aid, application, or use of the disclosing Party’s
Confidential Information.

For the avoidance of doubt, Confidential Information that is also Product
Information is governed both by the terms of Section 12.1 and by the terms of
this Section ‎12.2.

12.3Authorized Disclosure.  FibroGen may disclose Product Information and each
Party may disclose Confidential Information belonging to the other Party to the
extent such disclosure is reasonably necessary in the following situations:

(a)filing or prosecuting FibroGen Patents in accordance with Article 9;

(b)regulatory filings and other filings with Governmental Authorities (including
Regulatory Authorities), including filings with the SEC or FDA, with respect to
a Product;

(c)prosecuting or defending litigation;

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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(d)complying with applicable laws and regulations, including regulations
promulgated by securities exchanges;

(e)disclosure to its Affiliates, employees, agents, and independent contractors,
and any licensees or Sublicensees, in each case only on a need-to-know basis and
solely in connection with the performance of this Agreement or the China
Agreement (and in the case of FibroGen, the Astellas Collaboration or any
Subsequent Agreement entered into pursuant to Section 7.4(c)), provided,
however, that each disclosee must be bound by obligations of confidentiality and
non-use at least equivalent in scope to those set forth in this Article 12 prior
to any such disclosure and provided, further, that the disclosing Party shall
cause such disclosee to comply with confidentiality and non-use obligations at
least as restrictive as those set forth in this Article 12;

(f)disclosure of the material terms of this Agreement to any bona fide potential
or actual investor, investment banker, acquirer, merger partner, or other
potential or actual financial partner, and in the case of FibroGen, to any
licensee or sublicensee of Products (including Astellas and its sublicensees);
provided that in connection with such disclosure, the disclosing Party shall
inform each disclosee of the confidential nature of such Confidential
Information and cause each disclosee to treat such Confidential Information as
confidential; and

(g)disclosure of any Inventions or status reports (including data from any
Clinical Trials) to any bona fide potential or actual investor, investment
banker, acquirer, merger partner, or other potential or actual financial
partner, and in the case of FibroGen, to any licensee of Products (including
Astellas and its sublicensees); provided that each disclosee must be bound by
obligations of confidentiality and non-use at least as restrictive as those set
forth in this Article 12 prior to any such disclosure.

Notwithstanding the foregoing, in the event FibroGen is required to make a
disclosure of Product Information or either Party is required to make a
disclosure of the other Party’s Confidential Information pursuant to Sections
12.3(a), 12.3(b), 12.3(c) or 12.3(d), it will, except where impracticable, use
Commercially Reasonable Efforts to secure confidential treatment of such
information.  In any event, the Parties agree to take all reasonable action to
avoid disclosure of Confidential Information hereunder.

12.4Publicity; Terms of Agreement.

(a)The Parties agree that the material terms of this Agreement are the
Confidential Information of both Parties, subject to the special authorized
disclosure provisions set forth in Section 12.3 and this Section 12.4.  The
Parties have agreed to make a joint public announcement of the execution of this
Agreement substantially in the form of the press release attached as Exhibit N
on or promptly after the Effective Date.

(b)After release of such press release, if either Party desires to make a public
announcement concerning the material terms of this Agreement or any activities
under this Agreement, such Party shall give reasonable prior advance notice of
the proposed text of such announcement to the other Party for its prior review
and approval (except as otherwise provided

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brackets, has been omitted because it is both (i) not material and (ii) would
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herein), such approval not to be unreasonably withheld, except that in the case
of a press release or governmental filing required by law, the disclosing Party
shall provide the other Party with such advance notice as it reasonably can and
shall not be required to obtain approval therefor.  A Party commenting on such a
proposed press release shall provide its comments, if any, within five (5)
Business Days after receiving the press release for review.  FibroGen shall have
the right to make a press release announcing the achievement of each milestone
under this Agreement as it is achieved, and the achievements of Regulatory
Approvals as they occur, subject only to the review procedure set forth in the
preceding sentence.  In relation to AstraZeneca’s review of such an
announcement, AstraZeneca may make specific, reasonable comments on such
proposed press release within the prescribed time for commentary, but shall not
withhold its consent to disclosure of the information that the relevant
milestone or Regulatory Approval has been achieved and triggered a payment
hereunder.  Neither Party shall be required to seek the permission of the other
Party to repeat any information regarding the terms of this Agreement that have
already been publicly disclosed by such Party, or by the other Party, in
accordance with this Section 12.4.

(c)The Parties acknowledge that either or both Parties may be obligated to file
a copy of this Agreement with the SEC or other Government Authorities.  Each
Party shall be entitled to make such a required filing, provided that it
requests confidential treatment of at least the commercial terms and sensitive
technical terms hereof and thereof to the extent such confidential treatment is
reasonably available to such Party.  In the event of any such filing, each Party
will provide the other Party with a copy of the Agreement marked to show
provisions for which such Party intends to seek confidential treatment and shall
reasonably consider and incorporate the other Party’s comments thereon to the
extent consistent with the legal requirements governing redaction of information
from material agreements that must be publicly filed.

12.5Publications.

(a)Subject to the International Committee of Medical Journal Editors (“ICMJE”)
Uniform Requirements for Manuscripts Submitted to Biomedical Journals and
applicable legal requirements, the JDC (with approval of the JSC) will determine
the overall strategy for publishing and presenting results of studies pertaining
to the Products and the JDC shall approve all publications in the Territory
prior to publication.

(b)Neither Party shall publicly present or publish results of studies carried
out under this Agreement (each such presentation or publication a “Publication”)
without the opportunity for prior review by the other Party, except to the
extent otherwise required by applicable laws or regulations, in which case
Section 12.4(c) shall apply with respect to disclosures required by applicable
securities laws and Section 12.3(b) shall apply with respect to disclosures
required for regulatory filings.  The submitting Party shall provide the other
Party the opportunity to review any proposed Publication at least thirty (30)
days prior to the earlier of its presentation or intended submission for
publication.  The submitting Party agrees, upon request by the other Party, not
to submit or present any Publication until the other Party has had thirty (30)
days to comment on any material in such Publication.  The submitting Party shall
consider the comments of the other Party in good faith, and no Publication shall
be submitted for publication without the approval of the JDC or JCC.  The
submitting Party shall provide the other Party a copy of the

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Publication at the time of the submission or presentation.  Notwithstanding the
foregoing, AstraZeneca shall not have the right to publish or present FibroGen’s
Confidential Information without FibroGen’s prior written consent, and FibroGen
shall not have the right to publish or present AstraZeneca’s Confidential
Information without AstraZeneca’s prior written consent.  Each Party agrees to
acknowledge the contributions of the other Party, and the employees of the other
Party, in all publications as scientifically appropriate.

ARTICLE 13

Term and Termination

13.1Term.  This Agreement shall become effective on the Effective Date and,
unless earlier terminated pursuant to this Article 13, shall remain in effect
until the date that AstraZeneca is no longer Developing or selling Products in
the Territory (the “Term”).  

13.2Termination by AstraZeneca at Will.  AstraZeneca shall have the right to
terminate this Agreement at any time upon one hundred eighty (180) days prior
written notice to FibroGen, either (a) in its entirety or (b) with respect to
one or more of the following (each a “region”): (i) the U.S., (ii) Asia, (iii)
Africa or (iv) one or more of Mexico, Brazil, Canada, India or Australia and New
Zealand (each considered a separate region).  During such one hundred eighty
(180) day period, AstraZeneca shall continue to perform all of its obligations
under this Agreement and shall continue to be responsible for all costs incurred
under the Agreement to be borne by AstraZeneca according to the Agreement during
such one hundred eighty (180) day period.

13.3Termination by AstraZeneca for Technical Product Failure. AstraZeneca may
terminate this Agreement in its entirety at any time after the Effective Date
effective upon written notice to FibroGen in the event of Technical Product
Failure, such notice to describe the basis for such Technical Product Failure in
reasonable detail; provided, however, that AstraZeneca shall not be entitled to
terminate this Agreement pursuant to this Section 13.3 if such Technical Product
Failure pertains only to one or several specific Collaboration Compound(s) or
Product(s) but does not affect (a) FG-4592 (if FG-4592 is then still being
Developed or Commercialized under this Agreement) or (b) any other Collaboration
Compound or Product then in a Phase 2 Clinical Trial or later stage of
Development or Commercialization under this Agreement.  Disputes related to
whether or not a Technical Product Failure has occurred will be resolved in
accordance with Section 14.8.

13.4Termination by Either Party for Breach.

(a)Breach.  Subject to Section 13.4(b), FibroGen shall have the right to
terminate this Agreement upon written notice to AstraZeneca if AstraZeneca
materially breaches its obligations under this Agreement and, after receiving
written notice from FibroGen identifying such material breach by AstraZeneca in
reasonable detail, fails to cure such material breach within ninety (90) days
from the date of such notice (or within thirty (30) days from the date of such
notice in the event such material breach is solely based upon AstraZeneca’s
failure to pay any

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material amounts due to FibroGen hereunder).  Subject to Section 13.4(b),
AstraZeneca shall have the right to terminate this Agreement upon written notice
to FibroGen if FibroGen materially breaches its obligations under this Agreement
and, after receiving written notice from AstraZeneca identifying such material
breach by FibroGen in reasonable detail, fails to cure such material breach
within ninety (90) days from the date of such notice (or within thirty (30) days
from the date of such notice in the event such material breach is solely based
upon FibroGen’s failure to pay any material amounts due to AstraZeneca
hereunder).  

(b)Disputed Breach.  If the alleged breaching Party disputes in good faith the
existence or materiality of a breach specified in a notice provided by the other
Party in accordance with Section 13.4(a), and such alleged breaching Party
provides the other Party notice of such dispute within such ninety (90) day (or
thirty (30) day, as the case may be) period, then the non-breaching Party shall
not have the right to terminate this Agreement under Section 13.4(a) unless and
until the arbitral tribunal, in accordance with Article 14, has determined that
the alleged breaching Party has materially breached the Agreement and such Party
fails to cure such breach within ninety (90) days following such arbitral
tribunal’s decision (except to the extent such breach is solely based on the
failure to make a payment when due, which breach must be cured within thirty
(30) days following such arbitral tribunal’s decision); provided that with
respect to a failure to pay amounts due, arbitration shall be conducted in
accordance with Article 14, except that it shall be conducted by only one
arbitrator and shall be resolved within ninety (90) days.  It is understood and
agreed that during the pendency of such dispute, all of the terms and conditions
of this Agreement shall remain in effect and the Parties shall continue to
perform all of their respective obligations hereunder.

(c)DFCI Agreement.  [ * ]

13.5Termination for Patent Challenge.  FibroGen may terminate this Agreement in
its entirety immediately upon written notice to AstraZeneca if AstraZeneca or
its Affiliates or Sublicensees (directly or indirectly, individually or in
association with any other person or entity) challenges the validity,
enforceability or scope of any FibroGen Patent in the Territory and such
challenge is not permanently withdrawn within ninety (90) days.

13.6Effects of Termination.  Upon any termination of this Agreement other than
pursuant to Section 13.3 for Technical Product Failure, the following shall
apply (in addition to any other rights and obligations under Section 13.8 or
otherwise under this Agreement with respect to such termination) and, in the
case of termination with respect to a particular region only, shall apply only
to the terminated region (it being understood that any reference below to the
“terminated region” will apply to the Territory as a whole if this Agreement is
terminated in its entirety):

(a)Rights and Licenses to the FibroGen Technology.  As from the effective date
of the termination, all licenses and rights to the FibroGen Technology granted
to AstraZeneca under Article 7 shall terminate with respect to the terminated
region, except to the extent and for so long as is necessary to permit
AstraZeneca to comply with its obligations under this Section 13.6, to dispose
of any remaining inventory of Products pursuant to Section 13.6(g) and to
perform

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any activity that cannot be terminated as of such date under applicable law,
including GCP, it being agreed that all such activities and responsibilities
shall be discontinued and ceased (unless otherwise agreed) by transitioning such
activities and responsibilities to FibroGen as soon as practicable and subject
to applicable law, including GCP.

(b)AstraZeneca Technology.  AstraZeneca hereby grants to FibroGen, effective
only upon the effective date of such termination, a non-exclusive, fully-paid,
perpetual, irrevocable, royalty-free license, with the right to grant multiple
tiers of sublicenses, under the AstraZeneca Technology, to research, develop,
make, have made, use, import, export, offer for sale, and sell Products in the
Field in the terminated region; provided that FibroGen shall indemnify, defend
and hold harmless AstraZeneca and each of the AstraZeneca Indemnitees as set
forth in Section 11.1 from and against any AstraZeneca Damages arising out of or
resulting from AstraZeneca Claims that arise or result from FibroGen’s, its
Affiliates’ or licensees’ activities performed under the foregoing license.

(c)Marks.  AstraZeneca shall assign to FibroGen all right, title and interest in
and to the Marks for the terminated regions (excluding any such Marks that
include, in whole or part, any corporate name or logo of AstraZeneca or its
Affiliate or Sublicensee or that relate to any other products of AstraZeneca or
its Affiliates).

(d)Regulatory Materials. AstraZeneca shall transfer and assign to FibroGen all
Regulatory Materials and Regulatory Approvals for Products in the terminated
regions, if any, that are Controlled by AstraZeneca or its Affiliates or
Sublicensees.

(e)Transition Assistance.  AstraZeneca shall, at no cost to FibroGen, provide
reasonable consultation and assistance for a period of no more than one hundred
eighty (180) days following the effective date of termination for the purpose of
transferring or transitioning to FibroGen, all AstraZeneca Know-How solely
related to a Product not already in FibroGen’s possession, and, at FibroGen’s
request, all then-existing commercial arrangements relating specifically to the
terminated region and the Products to the extent reasonably necessary or useful
for FibroGen to commence or continue developing, manufacturing, or
commercializing Products in the terminated region, and further to the extent
AstraZeneca is contractually able to do so.  The foregoing consultation and
assistance shall include, without limitation, assigning, upon request of
FibroGen, any agreements with Third Party suppliers or vendors that specifically
cover the supply or sale of Products in the Territory, to the extent such
agreements are assignable by AstraZeneca.  If any such contract between
AstraZeneca and a Third Party is not assignable to FibroGen (whether by such
contract’s terms or because such contract does not relate specifically to
Products) but is otherwise reasonably necessary or useful for FibroGen to
commence or continue developing, manufacturing, or commercializing Products,
then AstraZeneca shall reasonably cooperate with FibroGen to negotiate for the
continuation of such license and/or supply from such entity.  In any event, if
AstraZeneca is manufacturing bulk or finished Product under an agreement entered
into pursuant to Section 6.4, then AstraZeneca shall supply such bulk or
finished Product, as applicable, to FibroGen and Astellas, for a reasonable
transitional period (not to exceed twelve (12) months from the effective date of
the termination, subject to reasonable extension by FibroGen if AstraZeneca is
unable to timely effect the technology transfer required to have a Third Party

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manufacturer designated by FibroGen undertake the manufacturing
responsibilities) under the terms of such agreement until FibroGen either enters
into a separate agreement with such Third Party supplier or vendor or
establishes an alternate, validated source of supply for the Products. In
consideration of such supplies, FibroGen shall pay to AstraZeneca a price equal
to AstraZeneca’s actual cost to manufacture or acquire such supplies, provided
that where termination is by AstraZeneca pursuant to Section 13.4(a), FibroGen
shall pay to AstraZeneca a price equal to AstraZeneca’s actual cost to
manufacture or acquire such supplies plus a mark-up [ * ] of such actual cost.

(f)Ongoing Clinical Trials.  As soon as practicable and subject to applicable
law, including GCP, AstraZeneca shall transfer to FibroGen the management and
continued performance of all Clinical Trials for Products for the terminated
regions ongoing as of the effective date of such termination, that are being
conducted by AstraZeneca at such time.

(g)Remaining Inventories. If this Agreement is terminated in its entirety,
FibroGen shall have the right to purchase from AstraZeneca any or all of the
inventory of Products held by AstraZeneca as of the effective date of the
termination (that are not committed to be supplied to any Third Party in the
ordinary course of business as of the date of termination) at a price equal to
AstraZeneca’s actual cost to acquire such inventory.  FibroGen shall notify
AstraZeneca within sixty (60) days after the effective date of the termination
whether FibroGen elects to exercise such right. In the event FibroGen does not
elect to exercise such right AstraZeneca shall be entitled to dispose of such
inventory as it sees fit in compliance with applicable law, subject to all
applicable payments to FibroGen under Article 8.

(h)Funding of Development Costs.  If AstraZeneca terminates this Agreement under
Section 13.2 (but not in the event of any other termination), then AstraZeneca
shall remain responsible for all (or, if during the Development Sharing Period,
fifty percent (50%) of) Development Costs and all Commercialization Costs
incurred by FibroGen under the respective Development Plans and
Commercialization Plans [ * ], under the process in Section 8.2. If AstraZeneca
terminates this Agreement under Section 13.2 (but not in the event of any other
termination), AstraZeneca shall [ * ].

(i)Post-Termination Restriction. If this Agreement is terminated by AstraZeneca
at will under Section 13.2 or by FibroGen under Section 13.4 for AstraZeneca’s
material breach or by FibroGen under Section 13.5 for patent challenge,
AstraZeneca shall continue to comply with the restrictive covenant set out in
Section 7.8(a) for three (3) years after the effective date of the termination.

(j)No Other Rights.  For the avoidance of doubt, the rights granted to FibroGen
under this Section 13.6 are restricted to Collaboration Compounds and Products
and AstraZeneca does not grant any rights whatsoever to any other compounds or
products or to any Patents or other intellectual property rights other than as
set forth in this Section 13.6. Moreover, AstraZeneca shall not be obligated to
provide FibroGen with any other intellectual property rights or other rights or
services than that which are explicitly provided for under this Section 13.6.

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(k)Certain Additional Provisions for Termination for FibroGen’s Breach.  If this
Agreement is terminated under Section 13.4 for FibroGen’s material breach,
FibroGen shall – in addition to any other remedies available to AstraZeneca
under this Agreement or applicable law as a consequence of such breach –
compensate AstraZeneca for any costs or expenses incurred by AstraZeneca or its
Affiliates in connection with performing any of the activities contemplated by
the applicable provisions in this Section 13.6.

13.7Effect of Termination for Technical Product Failure.  Upon termination of
this Agreement pursuant to Section 13.3 for a Technical Product Failure, all
licenses and rights to the FibroGen Technology granted to AstraZeneca under
Article 7 shall terminate and, to the extent appropriate given the nature of the
Technical Product Failure and subject to applicable law, including GCP, the
other termination consequences set out in Sections 13.6(a) through 13.6(g) as
well as Section 13.6(j) shall apply.

13.8Other Remedies.  Termination or expiration of this Agreement for any reason
shall not release either Party from any liability or obligation that already has
accrued prior to the effective date of such expiration or termination, nor
affect the survival of any provision hereof to the extent it is expressly stated
to survive such termination.  Termination or expiration of this Agreement for
any reason shall not constitute a waiver or release of, or otherwise be deemed
to prejudice or adversely affect, any rights, remedies or claims, whether for
damages or otherwise, that a Party may have hereunder or that may arise out of
or in connection with such termination or expiration.

13.9Bankruptcy.

(a)A Party shall have the right to terminate this Agreement in its entirety
before the end of the Term upon the bankruptcy or insolvency of, or the filing
of an action to commence insolvency proceedings against the other Party, or the
making or seeking to make or arrange an assignment for the benefit of creditors
of the other Party, or the initiation of proceedings in voluntary or involuntary
bankruptcy, or the appointment of a receiver or trustee of such Party’s
property, in each case that is not discharged within sixty (60) days of the
applicable filing, action or initiation of proceedings.

(b)All rights and licenses granted under or pursuant to this Agreement by
FibroGen and AstraZeneca are, and shall otherwise be deemed to be, for purposes
of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to
“intellectual property” as defined under Section 101 of the U.S. Bankruptcy
Code.  The Parties agree that each Party, as licensee of certain rights under
this Agreement, shall retain and may fully exercise all of its rights and
elections under the U.S. Bankruptcy Code.  The Parties further agree that, in
the event of the commencement of a bankruptcy proceeding by or against a Party
(such Party, the “Bankrupt Party”) under the U.S. Bankruptcy Code, the other
Party shall be entitled to a complete duplicate of (or complete access to, as
appropriate) any intellectual property licensed to such other Party and all
embodiments of such intellectual property, which, if not already in such other
Party’s possession, shall be promptly delivered to it (i) upon any such
commencement of a bankruptcy proceeding upon such other Party’s written request
therefor, unless the Bankrupt Party elects to continue to perform all of its

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brackets, has been omitted because it is both (i) not material and (ii) would
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obligations under this Agreement or (ii) if not delivered under clause (i),
following the rejection of this Agreement by the Bankrupt Party upon written
request therefor by the other Party.

13.10Survival.  Termination or expiration of this Agreement shall not affect
rights or obligations of the Parties under this Agreement that have accrued
prior to the date of termination or expiration of this
Agreement.  Notwithstanding anything to the contrary, the following provisions
shall survive and apply after expiration or termination of this Agreement:
Sections 3.10(b), 3.11, 4.4 (last sentence only), 7.8(a)-(c) (only as and to the
extent set forth in Section 13.6(i)), 7.8(d), 7.9, 8.1, 8.9-8.15, 9.2, 10.5,
12.1 (provided that all Product Information will be FibroGen’s Confidential
Information upon termination (but not expiration) of this Agreement), 12.2,
12.3, 12.4, 13.6, 13.7, 13.8 and 13.10 and Articles 11, 14 and 15.  In addition,
the other applicable provisions of Article 8 shall survive to the extent
required to make final reimbursements, reconciliations or other payments with
respect to Net Sales and costs and expenses incurred or accrued prior to the
date of termination or expiration.  For any surviving provisions requiring
action or decision by a Committee or an Executive Officer, each Party will
appoint representatives to act as its Committee members or Executive Officer, as
applicable.  All provisions not surviving in accordance with the foregoing shall
terminate upon expiration or termination of this Agreement and be of no further
force and effect.

ARTICLE 14

Dispute Resolution and Governing Law

14.1Disputes. It is the objective of the Parties to establish procedures to
facilitate the resolution of disputes arising under this Agreement in an
expedient manner by mutual cooperation and without resort to litigation.  In the
event of any disputes, controversies or differences which may arise between the
Parties out of or in relation to or in connection with this Agreement (including
disputes arising from the JSC that are not resolved pursuant to Section 2.6),
including, without limitation, any alleged failure to perform, or breach, of
this Agreement, or any issue relating to the interpretation or application of
this Agreement (each, a “Dispute”), then upon the request of either Party by
written notice, the dispute will be referred to the Executive Officers of each
Party, who shall meet and discuss in good faith a possible resolution thereof,
which good faith efforts shall include at least one in-person meeting.  If the
matter is not resolved within thirty (30) days following the written request for
discussions, either Party may then invoke the provisions of Section 14.2.

14.2Arbitration.  Any dispute, controversy, difference or claim which may arise
between the Parties, out of or in relation to or in connection with this
Agreement (including, without limitation, arising out of or relating to the
validity, construction, interpretation, enforceability, breach, performance,
application or termination of this Agreement) that is not resolved pursuant to
Section 14.1, except for a dispute, claim or controversy under Section 14.7 or
14.8, shall be settled by binding arbitration administered by the American
Arbitration Association (the “AAA”) in accordance with its Commercial
Arbitration Rules (or the AAA International Arbitration Rules, if recommended
under the AAA guidelines), as such rules may be modified by this Section 14.2 or
otherwise by subsequent written agreement of the Parties. The arbitration shall

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be governed by the U.S. Federal Arbitration Act, 9 U.S.C. §§ 1-16 (the “Federal
Arbitration Act”), to the exclusion of any inconsistent state laws.  The
arbitration will be conducted in New York, New York.  The number of arbitrators
shall be three (3), of whom the Parties shall select one (1) each. The two
arbitrators so selected will select the third and final arbitrator. If the
arbitrators selected by the Parties are unable or fail to agree upon the third
arbitrator, the AAA shall select the third arbitrator.  The language to be used
in the arbitral proceedings will be English.  The Parties shall have the right
to be represented by counsel.  The arbitration proceeding shall be
confidential.  Except as required by applicable law, no Party shall make (or
instruct the arbitrator to make) any public announcement with respect to the
proceedings or decision of the arbitrator without prior written consent of the
other Party.  The existence of any dispute submitted to arbitration, and the
award, shall be kept in confidence by the Parties and the arbitrator, except as
required in connection with the enforcement of such award or as otherwise
required by applicable law. Any judgment or award rendered by the arbitrators
shall be final and binding on the Parties.  The Parties agree that such judgment
or award may be enforced in any court of competent jurisdiction.

14.3Governing Law.  Resolution of all Disputes and any remedies relating thereto
shall be governed by and construed under the substantive laws of the State of
California, excluding any conflicts or choice of law rule or principle that
might otherwise refer construction or interpretation of this Agreement to the
substantive law of another jurisdiction.

14.4Decision.  The arbitrators shall issue a reasoned opinion following a full
comprehensive hearing, no later than twelve (12) months following the selection
of the arbitrators.

14.5Award.  Any award shall be promptly paid in Dollars free of any tax,
deduction or offset; and any costs, fees or taxes incident to enforcing the
award shall, to the maximum extent permitted by law, be charged against the
Party resisting enforcement.  If as to any issue the arbitrators should
determine under the applicable law that the position taken by a Party is
frivolous or otherwise irresponsible or that any wrongdoing it finds is in
callous disregard of law and equity or the rights of the other Party, the
arbitrators shall also be entitled to award an appropriate allocation of the
adversary’s reasonable attorney fees, costs and expenses to be paid by the
offending Party, the precise sums to be determined after a bill of attorney
fees, expenses and costs consistent with such award has been presented following
the award on the merits.  Each Party agrees to abide by the award rendered in
any arbitration conducted pursuant to this Article 14.  The award shall include
interest from the date of any damages incurred for breach of the Agreement, and
from the date of the award until paid in full, at a rate fixed by the
arbitrators.  With respect to money damages, nothing contained herein shall be
construed to permit the arbitrators or any court or any other forum to award
punitive or exemplary damages.  By entering into this agreement to arbitrate,
the Parties expressly waive any claim for punitive or exemplary damages.  The
only damages recoverable under this Agreement are compensatory damages.

14.6Injunctive Relief.  Provided a Party has made a sufficient showing under the
rules and standards set forth in the U.S. Federal Rules of Civil Procedure and
applicable case law, the arbitrator shall have the freedom to invoke, and the
Parties agree to abide by, injunctive measures after either Party submits in
writing for arbitration claims requiring immediate relief.  Nothing in

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this Article 14 will preclude either Party from seeking equitable relief or
interim or provisional relief from a court of competent jurisdiction, including
a temporary restraining order, preliminary injunction or other interim equitable
relief, concerning a dispute either prior to or during any arbitration if
necessary to protect the interests of such Party or to preserve the status quo
pending the arbitration proceeding.

14.7Patent and Trademark Disputes.  Any dispute, controversy or claim relating
to the scope, validity, enforceability or infringement of any patents or
trademarks covering the manufacture, use, importation, offer for sale or sale of
the Product shall be submitted to a court of competent jurisdiction in the
country in which such patent or trademark rights were granted or arose.

14.8Expedited Arbitration for Disputes Related to Technical Product
Failure.  Disputes with respect to a Technical Product Failure that are not
resolved at the JSC or by the Executive Officers within twenty (20) Business
Days after referral thereto, in the case of a Technical Product Failure as
defined in Section 1.120(a), or resolved by the Parties, in the case of a
Technical Product Failure as defined in Section 1.120(b), shall be finally
determined as set forth in this Section 14.8.  Within five (5) Business Days
after the end of such twenty (20)-Business Day period, each Party shall propose
a list of three (3) individuals, each of whom has at least ten (10) years of
significant relevant technical experience in the pharmaceutical industry, and
none of whom is or has been affiliated with either Party or with either Party’s
Affiliates, licensees, sublicensees or business partners, or otherwise has any
interest in the resolution of the issue to be submitted by the Parties for
resolution (the foregoing requirements, the “Requirements”).  Within five (5)
Business Days after the Parties exchange such lists, the Parties shall either
agree upon one of such proposed individuals to resolve the disputed matter, or
if the Parties do not so select one such individual within such period of time,
each Party shall select one (1) such individual from the list proposed by the
other Party, and the two (2) selected individuals shall select a third
individual who otherwise meets the Requirements to resolve the disputed matter
(the selected individual, the “Industry Expert”).  Each Party shall submit
written materials to the other Party and to the Industry Expert relating to the
matters in issue within five (5) Business Days after the Industry Expert is
selected. Each Party shall then have five (5) Business Days to submit a written
rebuttal to the other Party’s submission to the other Party and to the Industry
Expert.  The Industry Expert shall have the discretion to interview the Parties’
officers and employees to obtain further information relating to the matters in
issue and to hear oral argument.  Each Party shall cooperate with the Industry
Expert.  The Industry Expert’s determination shall be binding as to whether a
Technical Product Failure has occurred, and such determination shall be given
retroactive effect.  Until such determination is delivered to the Parties, the
Parties shall continue to perform their obligations under this Agreement in good
faith and make any applicable payments accordingly.  If the Industry Expert
decides in AstraZeneca’s favor, then the Parties shall bear all expenses
incurred pursuant to this Section 14.8 equally, and if the Industry Expert
decides in FibroGen’s favor, then AstraZeneca shall bear all expenses incurred
pursuant to this Section 14.8, including reasonable reimbursement of FibroGen’s
expenses for internal personnel and external advisors.

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brackets, has been omitted because it is both (i) not material and (ii) would
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ARTICLE 15

Miscellaneous

15.1Entire Agreement; Amendment.  This Agreement, including the Exhibits hereto,
sets forth the complete, final and exclusive agreement and all the covenants,
promises, agreements, warranties, representations, conditions and understandings
between the Parties hereto with respect to the subject matter hereof and
supersedes, as of the Effective Date, all prior agreements and understandings
between the Parties with respect to the subject matter hereof, including,
without limitation, the Existing Confidentiality Agreement.  The foregoing shall
not be interpreted as a waiver of any remedies available to either Party as a
result of any breach, prior to the Effective Date, by the other Party of its
obligations pursuant to the Existing Confidentiality Agreement.  In the event of
any inconsistency between any plan hereunder (including the Development Plan
and/or U.S. Commercialization Plan) and this Agreement or between the terms of
this Agreement and the China Agreement (but solely with respect to the U.S. and
RoW), the terms of this Agreement shall prevail.  There are no covenants,
promises, agreements, warranties, representations, conditions or understandings,
either oral or written, between the Parties other than as are set forth herein
and therein.  No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties unless reduced to writing and signed
by an authorized officer of each Party.

15.2Force Majeure.  Both Parties shall be excused from the performance of their
obligations under this Agreement to the extent that such performance is
prevented or delayed by force majeure and the nonperforming Party promptly
provides notice of the prevention to the other Party.  Such excuse shall be
continued so long as the condition constituting force majeure continues and the
nonperforming Party takes reasonable efforts to remove the condition.  For
purposes of this Agreement, force majeure shall mean conditions beyond the
control of the Parties, including without limitation, an act of God, war, civil
commotion, terrorist act, labor strike or lock-out, epidemic, failure or default
of public utilities or common carriers, destruction of production facilities or
materials by fire, earthquake, storm or like catastrophe, and failure of plant
or machinery (provided that such failure could not have been prevented by the
exercise of skill, diligence, and prudence that would be reasonably and
ordinarily expected from a skilled and experienced person engaged in the same
type of undertaking under the same or similar circumstances).  The
non-performing Party shall within thirty (30) days after a force majeure provide
the other Party a good faith estimate of the anticipated duration and any action
being taken to avoid or minimize its effect.  The suspension of performance
shall be of no greater scope and no longer duration than is reasonably necessary
and the non-performing Party shall use Commercially Reasonable Efforts to remedy
its inability to perform.  Notwithstanding the foregoing, a Party shall not be
excused from making payments owed hereunder because of a force majeure affecting
such Party.

15.3Notices.  Any notice required or permitted to be given under this Agreement
shall be in writing, shall specifically refer to this Agreement, and shall be
addressed to the appropriate Party at the address specified below or such other
address as may be specified by such Party in writing in accordance with this
Section 15.3, and shall be deemed to have been given for all

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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purposes (a) when received, if hand-delivered or sent by a reputable
international expedited delivery service, or (b) five (5) Business Days after
mailing, if mailed by first class certified or registered mail, postage prepaid,
return receipt requested.

 

If to FibroGen:

 

FibroGen, Inc.

 

 

409 Illinois St.

 

 

San Francisco, CA 94158

 

 

USA

 

 

Attention: Chief Executive Officer

 

 

 

With a copy to:

 

FibroGen, Inc.

 

 

409 Illinois St.

 

 

San Francisco, CA 94158

 

 

USA

 

 

Attn:  Michael Lowenstein, Vice President, Legal

 

If to AstraZeneca:

 

AstraZeneca AB

 

 

Pepparedsleden 1, 431 83 Mölndal

 

 

Gothenburg

 

 

Sweden

 

 

Attention: Chief Financial Officer

 

 

 

With a copy to:

 

AstraZeneca UK Limited

 

 

Alderley Park

 

 

Macclesfield

 

 

Cheshire SK10 4TF

 

 

Attention: Liam McIlveen, Deputy General Counsel

 

15.4No Strict Construction; Headings.  Each of the Parties acknowledges and
agrees that this Agreement has been diligently reviewed by and negotiated by and
between them, that in such negotiations each of them has been represented by
competent counsel and that the final agreement contained herein, including the
language whereby it has been expressed, represents the joint efforts of the
Parties hereto and their counsel.  Accordingly, in the event an ambiguity or a
question of intent or interpretation arises, this Agreement will be construed as
if drafted jointly by the Parties and no presumption or burden of proof will
arise favoring or disfavoring any Party by virtue of the authorship of any
provisions of this Agreement.  The headings of each Article and Section in this
Agreement have been inserted for convenience of reference only and are not
intended to limit or expand on the meaning of the language contained in the
particular Article or Section.

15.5Assignment.  Neither Party may assign or transfer this Agreement (either in
whole or part) or any rights or obligations hereunder without the prior written
consent of the other, except that a Party may make such an assignment or
transfer without the other Party’s consent to Affiliates or to a successor to
substantially all of the business of such Party, whether in a merger, sale of
stock, sale of assets or other transaction.  Any permitted successor or assignee
of rights and/or obligations hereunder shall, in a writing to the other Party,
expressly assume performance of such

94.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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rights and/or obligations (and in any event, any Party assigning this Agreement
to an Affiliate shall remain bound by the terms and conditions hereof).  In the
event that a Party is acquired by a Third Party (such Third Party, hereinafter
referred to as an “Acquiror”), then the intellectual property of such Acquiror
held or developed by such Acquiror (whether prior to or after such acquisition)
shall be excluded from the FibroGen Technology (in the case when the acquired
Party is FibroGen) and AstraZeneca Technology (in the case when the acquired
Party is AstraZeneca), and such Acquiror (and Affiliates of such Acquiror which
are not controlled by the acquired Party itself) shall be excluded from
“Affiliate” solely for purposes of the applicable components of the foregoing
intellectual property definitions, in all such cases if and only if: (a) the
acquired Party remains a wholly-owned subsidiary of the Acquiror; (b) all
intellectual property of the acquired Party and all research and development
assets and operations of the acquired Party with respect to the Product remain
with the acquired Party and are not transferred to the Acquiror or another
Affiliate of the Acquiror; (c) the scientific and development activities with
respect to Product of the acquired Party and the Acquiror (if any) are
maintained separate and distinct, and (d) there is no exchange of confidential
Information relating to this Collaboration between the acquired Party and the
Acquiror.  For clarity, in the event that a Party is acquired by an Acquiror and
any of the criteria described in subsections (a) through (d) is not satisfied,
then the intellectual property of such Acquiror shall be included within
FibroGen Technology (in the case when the acquired Party is FibroGen) and
AstraZeneca Technology (in the case when the acquired Party is
AstraZeneca).  Any permitted assignment of the rights and obligations of a Party
under this Agreement shall be binding on the successors of the assigning
Party.  Any assignment or attempted assignment by either Party in violation of
the terms of this Section 15.5 shall be null, void and of no legal effect.

15.6Performance by Affiliates.  Subject to the limitations of Section 7.3, each
Party may discharge any obligations and exercise any right hereunder through any
of its Affiliates.  Each Party hereby guarantees the performance by its
Affiliates of such Party’s obligations under this Agreement, and shall cause its
Affiliates to comply with the provisions of this Agreement in connection with
such performance.  Any breach by a Party’s Affiliate of any of such Party’s
obligations under this Agreement shall be deemed a breach by such Party, and the
other Party may proceed directly against such Party without any obligation to
first proceed against such Party’s Affiliate.

15.7Further Actions. Each Party agrees to execute, acknowledge and deliver such
further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

15.8Compliance with Applicable Law.  Each Party shall comply with all applicable
laws and regulations in the course of performing its obligations or exercising
its rights pursuant to this Agreement.

15.9Limitation of Liability.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY
SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM
OR RELATING TO ANY BREACH OF THIS AGREEMENT OR ANY TORT CLAIMS ARISING
HEREUNDER, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH
DAMAGES.  NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 15.9 IS
INTENDED TO OR SHALL LIMIT OR

95.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION
11.1, 11.2 OR 11.3, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ITS
CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 12.

15.10Severability.  To the fullest extent permitted by applicable law, each
Party hereby waives any provision of law that would render any provision hereof
illegal, invalid or unenforceable in any respect. If any one or more of the
provisions of this Agreement is held to be invalid or unenforceable by an
arbitrator or by any court of competent jurisdiction from which no appeal can be
or is taken (within the time period prescribed for appeal), the provision shall
be considered severed from this Agreement and shall not serve to invalidate any
remaining provisions hereof.  The Parties shall make a good faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one
that achieves, as nearly as possible, the objectives contemplated by the Parties
when entering this Agreement.

15.11No Waiver. Any delay in enforcing a Party’s rights under this Agreement or
any waiver as to a particular default or other matter shall not constitute a
waiver of such Party’s rights to the future enforcement of its rights under this
Agreement, except with respect to an express written and signed waiver relating
to a particular matter for a particular period of time.

15.12Independent Contractors.  It is expressly agreed that FibroGen, on the one
hand, and AstraZeneca, on the other hand, shall be independent contractors and
that the relationship between the two Parties shall not constitute a
partnership, joint venture or agency.  Neither FibroGen, on the one hand, nor
AstraZeneca, on the other hand, shall have the authority to make any statements,
representations or commitments of any kind, or to take any action that will be
binding on the other, without the prior written consent of the other Party to do
so.  All persons employed by a Party shall be employees of such Party and not of
the other Party and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such first Party.

15.13English Language.  This Agreement shall be written and executed in and all
other communications under or in connection with this Agreement shall be in, the
English language.  Any translation into any other language shall not be an
official version thereof and in the event of any conflict in interpretation
between the English version and such translation, the English version shall
control.

15.14Counterparts.  This Agreement may be executed in one (1) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

[Signature Page Follows]

 

96.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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In Witness Whereof, the Parties have executed this Agreement in duplicate
originals by their duly authorized officers as of the Execution Date.

 

FibroGen, Inc.

 

AstraZeneca AB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ Thomas B. Neff

 

By:

 

/s/ Elisabeth Bjork

 

 

 

 

 

 

 

 

 

Name:

 

Thomas B. Neff

 

Name:

 

Elisabeth Bjork

 

 

 

 

 

 

 

 

 

Title:

 

CEO

 

Title:

 

VP, GMed Head, CVMD

 

 

 

Signature Page to Amended and Restated

 

License, Development and Commercialization Agreement

 

97.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXHIBITS

Exhibit A – Territory – Excluded Countries

Exhibit B – DFCI Agreement

Exhibit C – Chemical Structure of FG-4592

Exhibit D – Field Indications

Exhibit E – Listed Patents

Exhibit F – AstraZeneca’s Anti-Corruption Rules and Policies

Exhibit G – Initial Members of the JSC

Exhibit G(a) – JDC Responsibilities Delegated by the JSC to the Core JPT

Exhibit G(b) – JCC Responsibilities Delegated by the JSC to the Core JPT

Exhibit H – Initial Development Plan

Exhibit I – U.S. Co-Commercialization Terms

Exhibit J – Development Supply Terms

Exhibit K – Commercial Supply Terms

Exhibit L – Invoicing Requirements

Exhibit M – Patents that May be Extended

Exhibit N – Joint Press Release

 

98.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Exhibit A

Excluded Countries

 

 

•

Albania

•

Andorra

•

Armenia

•

Austria

•

Azerbaijan

•

Belarus

•

Belgium

•

Bosnia & Herzegovina

•

Bulgaria

•

Croatia

•

Cyprus

•

Czech Republic

•

Denmark

•

Estonia

•

Finland

•

France

•

Georgia

•

Germany

•

Greece

•

Hungary

•

Iceland

•

Ireland

•

Italy

•

Japan

•

Kazakhstan

•

Kyrgyzstan

•

Latvia

•

Liechtenstein

•

Lithuania

•

Luxembourg

•

Macedonia

•

Malta

•

Moldova

•

Monaco

•

Netherlands

•

Norway

•

Poland

•

Portugal

•

Romania

•

Russia

•

San Marino

•

Serbia and Montenegro (Yugoslavia)

•

Slovakia

•

Slovenia

•

Spain

•

Sweden

•

Switzerland

•

Tajikistan

•

Turkey

•

Turkmenistan

•

Ukraine

•

United Kingdom

•

Uzbekistan

•

Vatican City

•

Bahrain

•

Egypt

•

Iran

•

Iraq

•

Israel

•

Jordan

•

Kuwait

•

Lebanon

•

Oman

•

Qatar

•

Saudi Arabia

•

Syria

•

United Arab Emirates

•

Yemen

•

South Africa

 

1

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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Exhibit B

DFCI Agreement

{This Exhibit B is filed as Exhibit 10.24 to the Registration Statement on Form
S-1 (Commission File No. 333-199069)}

 

 

1

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

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Exhibit C

Chemical Structure of FG-4592

[ * ]

 

 

1

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

CONFIDENTIAL

 

Exhibit D

Field Indications

[ * ]

 

 

1

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

CONFIDENTIAL

 

Exhibit E

Listed Patents

[ * ]

 

 

1

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

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Exhibit F

AstraZeneca’s Anti-Corruption Rules and Policies

ASTRAZENECA GLOBAL POLICY

ETHICAL INTERACTIONS

ANTI-BRIBERY & ANTI-CORRUPTION

EXTERNAL INTERACTIONS

This Global Policy describes what is required to meet our commitment to operate
ethically and with integrity in our business and personal interactions and
activities.

This Policy applies to all Employees.

The Company is committed to acting responsibly and in compliance with the
requirements of the UK Bribery Act, Foreign Corrupt Practices Act and other
relevant laws, regulations and adopted industry codes

CONTENTS

1. SCOPE, APPLICATION & INTERPRETATION.

2. ANTI-BRIBERY & ANTI-CORRUPTION

3. ITEMS OF VALUE & HOSPITALITY

4. PRICING, DISCOUNTS & REBATES

5. CONTRIBUTIONS (DONATIONS, SPONSORSHIPS & PARTNERSHIPS)

6. POLITICAL SUPPORT & POLITICAL ACTIVITIES

7. PAYMENTS TO PUBLIC OFFICIALS & PUBLIC SECTOR ORGANISATIONS

8. AVOIDING CONFLICTS OF INTEREST

9. MEETINGS

10. ENGAGING THIRD PARTIES & ENSURING COMPLIANCE

11. PROMOTIONAL & NON-PROMOTIONAL ACTIVITIES & MATERIALS

12. PRE-AUTHORISATION ACTIVITIES & MATERIALS

13. NON-INTERVENTIONAL STUDIES 6

14. INVESTIGATOR SPONSORED STUDIES

GLOSSARY REFERENCES

1. SCOPE, APPLICATION & INTERPRETATION

1.1 This Policy applies to all Employees and represents the minimum requirements
that the Company has set for Interactions.

An alphabetised Glossary containing definitions for all capitalised terms used
in this Policy is included at the end of this Policy.

1

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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For certain Interactions, You must refer to more than one Section of this
Policy. The relevant Sections are cross-referenced as appropriate.

Other Global Policies may also apply to Interactions. For example, the Global
Data Privacy Policy applies to Interactions where there is a need to protect the
confidentiality of Patient information.

Global Standards may also apply to Interactions. The Global Standards give
additional information about what is required to ensure compliance for
particular Interactions. The requirements of this Policy and of the supporting
Global Standards must be considered as a whole to evaluate and support compliant
Interactions. Global Standards are cross-referenced in each relevant section of
this Policy.

1.2 This Policy expands on the Company’s Code of Conduct, and aligns with (and
in some cases exceeds) the requirements of applicable law and adopted industry
codes.

You must follow the spirit of this Policy and not just its letter. The absence
of a specific requirement relating to a particular Interaction does not mean
that the Interaction is necessarily permitted; You must avoid any Interaction
that breaches the Company’s Code of Conduct or supporting Global Policies,
Global Standards or Relevant Procedures.

1.3 Employees must not attempt to avoid the requirements of this Policy by
requesting, allowing or enabling Third Parties (including relatives, friends or
other associates) to be involved in the Interactions prohibited by this Policy
on the Employee’s (or the Company’s) behalf.

In some cases, local law, adopted industry codes particular to a jurisdiction,
or rules particular to a Business Unit (e.g., Senior Executive Team (“SET”)
function), may apply to Interactions, and may be more restrictive than this
Policy. Where that is the case, You must follow the more restrictive rules set
out in Relevant Procedures. For example, local marketing organisations must
establish Relevant Procedures with respect to Interactions with Public
Officials, where local law is more restrictive than this Policy.

To the extent appropriate, Business Units must establish Relevant Procedures to
assure compliance with the requirements of this Policy and supporting Global
Standards, including requirements for sufficient monitoring and/or audit.
Employees must use reasonable judgement to create business records sufficient to
demonstrate compliance with the requirements of this Policy, supporting Global
Standards and these Relevant Procedures (e.g., business records of required
approvals and required rationales for approvals).

For purposes of this Policy, required approvals must be obtained in advance of
any Interaction.

Where the scope or interpretation of a particular provision of this Policy,
supporting Global Standards or Relevant Procedures is unclear, You should seek
guidance from Your line manager or Your relevant Legal and/or Compliance
partner.

2

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

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2. ANTI-BRIBERY & ANTI-CORRUPTION

2.1 AstraZeneca has zero tolerance for Bribery or corruption (i.e., improper
influence).

The Company will support Employees and Third Parties who refuse requests to Give
or Receive Bribes on the Company’s behalf. Employees and Third Parties will not
be subject to retaliation or other adverse consequences for such refusal, even
if the Company loses business as a result.

See Section 7 for prohibitions and other requirements regarding Facilitation
Payments, including payments Given under duress.

2.2 You may Give or Receive something of value in compliance with the
requirements and limits of this Policy, supporting Global Standards and Relevant
Procedures.

For purposes of this Policy, supporting Global Standards and Relevant
Procedures, “something of value” means any financial or non-financial benefit of
any kind, including, but not limited to:

a) the Giving and Receiving of Items of Value and Hospitality (See Section 3 and
the Global Standard on Items of Value and Hospitality);

b) prices, discounts and rebates for Company Products Given to Third Parties
(See Section 4);

c) Contributions Given to Third Parties (See Section 5 and the Global Standard
on Contributions);

d) Political Support Given to Public Officials or Political Organisations and
participation in Political Activities (See Section 6);

e) payments Given to Public Officials and Public Sector Organisations (See
Section 7);

f) appointments, paid and volunteer work outside of the Company or other
interests associated with actual, apparent or potential Conflicts of Interest
(See Section 8);

g) the venue, conduct or other arrangements made for Meetings, as well as the
selection and/or support of External Stakeholders to attend Meetings or
independent congresses, including professional education credits and
capability-building sessions (See Section 9 and the Global Standard on
Meetings);

h) the engagement of Third Parties to provide Services, including compensation
and expense reimbursement (See Section 10 and the Global Standard on Engaging
Third Parties); and

i) support for External Stakeholders for Non-Interventional Studies and
Investigator Sponsored Studies (See Sections 13 and 14).

3

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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2.3 You must not Give or Receive something of value that is intended or could be
seen as improper influence.

If you are in doubt about any Interaction, you must consult with your line
manager or your relevant Legal and/or Compliance partner for appropriate
guidance.

2.4 All monetary payments by the Company to Third Parties that are permitted by
this Policy must be made via an approved Company financial payment system by
bank transfer, cheque or company credit card, must not take the form of cash or
cash equivalent (e.g., debit cards, gift cards, gift certificates), and must be
accurately and appropriately recorded in the Company’s books and records.

All such payments may also be made via a specifically authorised Third Party
(unless otherwise noted in this Policy or supporting Global Standards), when
genuine business needs require, and Relevant Procedures (with adequate controls)
support such an arrangement. In such cases, the Third Party must be
contractually obligated to accurately document, track and report to the Company
the amounts paid on its behalf, as required by the Relevant Procedures.

This Section 2.4 prohibits cash and cash equivalent payments by Employees (or
Third Parties acting on the Company’s behalf), except as specifically permitted
by Relevant Procedures established or approved by the Global Finance function.
Also, see paragraph 1.18 of the Global Standard on Items of Value and
Hospitality for requirements regarding exceptional Cultural Courtesy Gifts in
the form of cash or cash equivalent.

2.5 You must not Give a Bribe.

Give means to directly or indirectly offer, promise or give, or to authorise
such actions.

You must not Give something of value to any Third Party or any fellow Employee
that is intended or could be seen to:

a) influence or reward an official action or decision (e.g., by a Public
Official);

b) enable or induce a Third Party or fellow Employee to perform their function
improperly, or make any decision or take any action favourable to the interests
of the Company (or You) on an improper basis, or reward them for doing so;

c) provide incentive or reward to a Third Party for past, present or future
willingness to prescribe, administer, recommend, purchase, pay for, reimburse,
authorise, approve, supply or use any Company Product or service; or

d) obtain or retain improper business, or secure any improper professional or
personal advantage.

4

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

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2.6 You must not Receive a Bribe.

Receive means to directly or indirectly solicit, agree to receive or accept, or
to authorise such actions. You must not Receive something of value from any
Third Party or any fellow Employee that is intended or could be seen to:

a) compromise Your independence or judgement;

b) enable or induce You to perform Your function improperly, or make any
decision or take any action favourable to the interests of the Third Party (or
fellow Employee) on an improper basis, or reward You for doing so; or

c) obtain or retain improper business, or secure any improper professional or
personal advantage.

3. ITEMS OF VALUE & HOSPITALITY

3.1 You must not Give or Receive Items of Value or Hospitality that are intended
or could be seen as improper influence.

To the extent appropriate, Business Units must establish Relevant Procedures on
actual or perceived value and frequency when Giving and Receiving Items of Value
and Hospitality. These Relevant Procedures must include specific limits on value
(modest) and frequency (occasional) and definitions for “modest” and
“occasional,” to guide Employees on appropriate value and frequency levels that
would not create actual or perceived improper influence, taking into account
local custom and practice (See paragraph 2.1 of the Global Standard on
Meetings).

To the extent appropriate, Business Units must establish Relevant Procedures to
enable the Company to satisfy transparency obligations, with respect to the
Giving of Items of Value and Hospitality to External Stakeholders.

Items of Value and Hospitality that exceed Company limits, either separately or
in total, to or from the same individual or organisation, are prohibited.

Any Giving or Receiving of Items of Value or Hospitality that is based upon a
genuine personal relationship independent of the Company and that is personally
funded by the individuals involved (without Company reimbursement) is
permissible and is not restricted by this Policy, if it is not intended and
could not be seen as improper influence.

3.2 See Section 2 of this Policy and the Global Standard on Items of Value and
Hospitality for further requirements on Items of Value and Hospitality.

5

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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4. PRICING, DISCOUNTS & REBATES

4.1 To the extent appropriate, Business Units must have an approved pricing
model in place, based on objective criteria, to govern the pricing, rebates and
discounts (and other commercial advantages or favourable terms) that can be
Given to Third Parties.

The pricing model must be reviewed on a regular basis by the head of the
relevant Business Unit or designee to ensure appropriateness and transparency.

These Business Units must document the purpose of any prices, rebates or
discounts (or other commercial advantages or favourable terms) Given to Third
Parties that fall outside the approved pricing model, and this documented
purpose must be approved by the head of the relevant Business Unit or designee
to ensure appropriateness and transparency.

4.2 See Section 2 of this Policy for further requirements on prices, discounts
and rebates.

5. CONTRIBUTIONS (DONATIONS, SPONSORSHIPS & PARTNERSHIPS)

5.1 The Company is committed to making a positive impact on Our local
communities and supporting the work of others in the healthcare and scientific
arenas.

Contributions may be classified as Donations, Sponsorships or Partnerships, and
may take the form of financial or non-financial support (e.g., funds or in-kind
assistance, such as resources, facilities or employee time).

Contributions may generally only be Given for legitimate scientific, educational
and/or charitable purposes to support the following: health or healthcare,
medical or scientific education, advances in medical or scientific research and
disaster relief. Contributions may also be Given for other purposes on an
exceptional basis, only with senior management approval, as set out in Relevant
Procedures.

For the avoidance of doubt, this Section does not prohibit individual Employees
from supporting charities and other organisations in a purely personal capacity
and without any involvement of the Company, if the support meets the
requirements of Section 8 of this Policy. This Section 5 also does not prohibit
Employees from organising charitable efforts on the Company premises (such as a
local food drive or book drive), with line manager approval, where Employees use
only their personal funds and resources to participate, if the support meets the
requirements of Section 8 of this Policy.

Generally, Contributions to support a Meeting or other event must only be Given
where the venue and location of the supported event are appropriate and
conducive to the intended purpose, and where any Meals or other Hospitality
provided by the Company or by the recipient of the Contribution are modest and
incidental to the purpose of the event. See the Global Standard on
Contributions, the Global Standard on Items of Value and Hospitality and the
Global Standard on Meetings for specific requirements and exceptions.

6

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.

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EXECUTION VERSION

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Certain charitable Donations, Sponsorships and Partnerships that meet the
relevant criteria described in the Global Standard on Contributions and the
Global Procedure and Guidance Community Investment specifically qualify as
Community Investment Contributions.

5.2 Contributions may only be given to reputable, recognised and independent
institutions or other legitimate, established organisations, and only for
legitimate purposes.

The relevant Business Unit managing the Contribution must conduct appropriate
due diligence on the proposed recipient of any Contribution to establish that
the proposed recipient satisfies the requirements of this Section 5.2 and to
establish that Contribution will be well used. In addition, the relevant
Business Unit may agree upfront with the recipient organisation to conduct
appropriate post-funding review (e.g., review of a summary of the completed
projects or other results of the

In addition to the requirements of Section 2, a Contribution must not be Given
for any other improper purpose or use, including, but not limited to, the
following:

a) to help offset an External Stakeholder’s cost of purchasing or reimbursing
Company Products or to influence any other decisions about listing, purchasing
or reimbursing of Company Products;

b) to organisations or activities that are known to discriminate on any unlawful
basis;

c) to support programming or editorial content containing gratuitous violence or
sexually explicit material or any activity that does not reflect the values
and/or mission of the Company, or could cause embarrassment to the Company; or
d) to support any activities prohibited by Relevant Procedures.

Contributions that might be considered as excessive or inappropriate in scale
and/or affiliation are not permitted.

Contributions must not be Given to avoid the restrictions on Giving Items of
Value and Hospitality to Third Parties (See Section 3 and the Global Standard on
Items of Value and Hospitality).

5.3 Contributions must not be Given to any organisation for the personal benefit
of any individual or Healthcare Professional (“HCP”) practice (i.e., a group of
HCPs sharing premises or other resources) selected by the Company, or to
disguise or conceal any such personal benefit (except as permitted in paragraph
4.5 of the Global Standard on Contributions regarding Fellowships and
Preceptorships for scientists to support research activities).

Contributions must not be Given by the Company directly to an individual or HCP
practice.

For the avoidance of doubt, direct Company support for individual External
Stakeholders to attend Meetings or independent congresses is not considered to
be a Contribution for purposes of this Policy and is permissible only in limited
circumstances (See section 3 of the Global Standard on Meetings).

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For the avoidance of doubt, awards to individuals are not considered
Contributions. See the Global Standard on Items of Value and Hospitality for
requirements regarding awards and awards ceremonies.

An individual who formally represents an organisation may request a Contribution
from the Company on behalf of the organisation, and such request must be
considered and processed as required by Relevant Procedures. Contributions must
not be Given to an organisation at the request of any other individual (e.g., to
a Public Official’s preferred charity), except for Sympathy Gifts Given to a
designated non-profit organisation as a memorial in the event of a death, or
Contributions Given at the request of an Employee as part of a Company matching
fund programme.

Contributions must not be Given to financially benefit HCPs or HCP practices by
replacing any assets or funding any activities that they would be expected or
required to provide themselves to fulfil obligations they have under local law,
contract or customary business practice. For example, Contributions must not be
Given to improve business efficiencies or administrative processes of an HCP or
HCP practice, such as support for billing or taxes. For the avoidance of doubt,
Contributions to support HCP education are permissible, in the interest of
improving Patient care and/or Patient health.

5.4 See Section 2 of this Policy and the Global Standard on Contributions for
further requirements on Contributions.

Contributions must not be Given by Third Parties on behalf of the Company,
except for Company Product Donations (See the Global Procedure and Guidance
Community Investment and the Global Guidance for Product Donations).

For the avoidance of doubt, Contributions do not include Political Support or
participation in Political

6. POLITICAL SUPPORT & POLITICAL ACTIVITIES

6.1 Employees must not Give Political Support on behalf of the Company unless
specifically authorised to do so by the Government Affairs function or the
Reviewer.

Third Parties must not Give Political Support on behalf of the Company under any
circumstance. The Company will not reimburse in any way or form any Third Party
or non-authorised Employee for Giving Political Support.

Political Support may only be Given where it is expressly permitted by local law
and where acceptable as part of local custom and practice.

All Political Support must be Given directly to the recipient organisation or
individual. The name of the organisation or individual, purpose, nature and
value of the Political Support and the date of the Political Support must be
properly documented and recorded in the Company’s books and records, to enable
public disclosure.

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The Government Affairs function will establish or approve Applicable Internal
Review Procedures for the Giving of Political Support.

6.2 Employees and Third Parties must not participate in Political Activities on
behalf of the Company unless specifically authorised to do so by the Government
Affairs function or the Reviewer.

The Government Affairs function will establish or approve Applicable Internal
Review Procedures for participation in Political Activities.

6.3 The Company recognises the rights of Employees to use their own funds, time
and other personal resources to Give Political Support or to participate in
Political Activities.

You must ensure that you do not act or appear to act as a representative of the
Company when participating in Political Activities or Giving Political Support
in a personal capacity. You must make it clear that your views and actions are
Your own, and that any Political Support You provide is Given on a personal
basis, using Your own funds, time or other personal resources.

6.4 See Section 2 of this Policy for further requirements on Political Support
and Political Activities.

7. PAYMENTS TO PUBLIC OFFICIALS & PUBLIC SECTOR ORGANISATIONS

7.1 The Company does not permit Employees or Third Parties providing Services to
Give Facilitation Payments, either directly or indirectly, to Public Officials
(including HCPs and other individuals employed by Public Sector Organisations),
regardless of whether such payments are nominal in amount.

Employees and Third Parties must not attempt to conceal or disguise Facilitation
Payments to avoid the requirements of this Section.

The nature of the Company’s business involves legitimate Interactions with a
range of Public Officials. Examples include Public Officials responsible for
issuing Company Product licences, making Company Product listing decisions,
determining Company Product pricing and payment, providing permits and
regulatory Authorisations and conducting facility inspections.

You may Give payments to individual Public Officials where they are engaged to
provide legitimate Services (See Section 10). You must not Give any other
payments to individual Public Officials unless such payments are required or
otherwise expressly permitted by local law and not otherwise prohibited by this
Policy.

You may Give legitimate and lawful payments to Public Sector Organisations with
respect to taxes, permits, licences, inspections and other fees required or
otherwise expressly permitted by local law and not otherwise prohibited by this
Policy. Official government receipts must be obtained to support all such
payments.

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7.2 The Company recognises that, in exceptional circumstances, payments may be
demanded under duress from Employees or Third Parties providing Services. It is
permissible for Employees and Third Parties to Give payments demanded under
duress, where there is reasonable fear for personal safety.

Duress describes situations of actual or threatened violence or imprisonment to
force a person to act against their will. The Company is committed to ensuring
the safety of its Employees and Third Parties and does not expect them to
compromise their safety in such situations.

Employees and Third Parties must promptly report in writing to their line
manager all incidents where:

a) Facilitation Payments are requested but not paid; or

b) payments are demanded under duress, whether paid or not.

The line manager must then promptly inform the relevant Legal partner of such
incidents in writing and ensure that any payments actually made are properly
documented and recorded in the Company’s books and records. The line manager
must also consult with the relevant Legal partner regarding the reporting of
such incidents to the relevant authorities and the steps to be taken to prevent
recurrence.

7.3 See Section 2 of this Policy for further requirements on payments to Public
Officials and Public Sector Organisations.

8. AVOIDING CONFLICTS OF INTEREST

8.1 You must ensure that Your interests, activities and associations outside of
the Company do not result in actual, apparent or potential Conflicts of Interest
with Your professional duties and decisions as an Employee, by directly or
indirectly compromising Your independence or professional judgement, or creating
an appearance of doing so.

You must not allow, or appear to allow, a personal relationship to influence
Your decision-making or judgement. You must ensure that the Company’s interests
are paramount when business opportunities are assessed and commercial decisions
are taken.

You may make personal financial investments, pursue other business interests and
maintain social relationships with people You meet through Your Employment, if
all of the relevant requirements of this Section of the Policy are met. You must
ensure that these Interactions do not result in actual, apparent or potential
Conflicts of Interest with the Company’s business activities.

You must not use Company resources or your position as an Employee for Your own
personal benefit or for the benefit of Your relatives, friends or other
associates.

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8.2 You must inform Your line manager in writing of any actual, apparent or
potential Conflicts of Interest at the time they become known. Engagement Owners
must also inform their line managers in writing of any actual, apparent or
potential Conflicts of Interest of a Third Party providing Services, at the time
they become known.

Line managers must provide written direction on how to resolve or avoid the
Conflict of Interest after obtaining any necessary advice from the relevant
Legal and/or Compliance partner.

If You, a relative or close friend has a financial or management interest in a
Third Party (other than a nominal shareholding interest through a
publicly-available investment), You must disclose the situation as a potential
Conflict of Interest to Your line manager. You must not participate in any
purchasing or other Company decisions related to that Third Party.

8.3 You must not do any volunteer or paid work outside of the Company related to
Your Company work responsibilities or work product (e.g., speaking engagement,
authoring or publishing) unless You obtain written approval from Your line
manager, on the basis that such work is unlikely to create an actual, apparent
or potential Conflict of Interest and on the basis that any payment is not
intended and could not be seen as improper influence.

For all such work, You may Receive necessary and modest travel, accommodation,
Meals and other directly related, incidental expenses, with written line manager
approval, on the basis that such expenses are not intended and could not be seen
as improper influence.

8.4 You must not accept any appointment to the Board of Directors of an external
organisation in the healthcare or scientific arena, unless You obtain written
approval from Your line manager.

Approval should not normally be provided for directorships of Third Parties who
are conducting, or may conduct, business directly within Your scope of
responsibility or where You will gain a financial benefit that could be open to
question or misinterpretation if publicly disclosed.

8.5 You must not use non-public Company information for personal gain.

You must not pass such information to anyone else (either inside or outside the
Company), who does not have a legitimate need for the information.

8.6 See Section 2 of this Policy for further requirements on Conflicts of
Interest.

9. MEETINGS

9.1 Organising or supporting Meetings with External Stakeholders is part of Our
business. Where doing so, You must follow the requirements listed in the Global
Standard on Meetings.

The location, venue, conduct and other arrangements made for Meetings must be
modest, conducive and appropriate to the purpose of the Meeting.

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9.2 Meetings must always have a scientific, medical education and/or other
legitimate business purpose, which must be clearly stated.

The Company may Give a Contribution (See Section 5) to a Meeting organiser to
support the conduct of a Meeting (e.g., a Sponsorship). Any such Contribution
must meet the relevant requirements of both the Global Standard on Contributions
and the Global Standard on Meetings, with respect to the substance of the
Meeting as well as the conduct and arrangements made for the Meeting.

9.3 See Section 2 of the Policy and the Global Standard on Meetings for further
requirements on Meetings.

The Global Standard on Meetings also includes specific requirements on Company
support for External Stakeholders to attend independent congresses.

10. ENGAGING THIRD PARTIES & ENSURING COMPLIANCE

10.1 The Company is committed to engaging only those Third Parties who embrace
standards of ethical behavior that are consistent with Our own.

Engagement Owners are accountable for ensuring that the Third Party’s reputation
and conduct are consistent with the Company’s ethical standards (See Section
10.5).

For the avoidance of doubt, engagements do not include informal, routine
business Interactions between Employees and Third Parties, where no Services are
provided and no payment is Given (e.g., informal discussions at professional
Meetings or independent congresses for scientific exchange, or routine phone
calls in the normal course of business).

10.2 Engagement Owners must engage a Third Party only where there is a genuine
business need for Third Party Services and must only engage the necessary and
appropriate Third Parties to provide those Services.

Engagement Owners must ensure that the selected Third Party has the relevant
qualifications, expertise, reputation, knowledge, experience and ability to
fulfill the genuine business need, and is the most appropriate choice to provide
the Services.

External Stakeholders may be engaged by the Company (either directly or through
a specifically authorised Third Party on the Company’s behalf) to provide
Services. Such Services include, but are not limited to: providing input and
information as an Advisor or consultant, speaking at Meetings (e.g., a
Promotional Speaker), acting as a clinical investigator or a study site, or
educating or otherwise presenting to Representatives at Representative training
or business cycle sessions. Patients and Other Third Parties may also be engaged
by the Company to provide Services.

Each engagement with an External Stakeholder or Patient for Services must be
documented in a signed contract. If the External Stakeholder or Patient is not
accepting compensation, or payment

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or reimbursement of expenses, the requirement for a signed contract may be
waived with documented line manager approval.

Each engagement with Other Third Parties for Services must be documented in the
format required for the particular Services to be provided, such as a contract,
Terms & Conditions, a Purchase Order or other required documentation of offer
and acceptance of Services.

Third Parties must not provide any Service on behalf of the Company, in
connection with the execution of an engagement or otherwise, unless the Service
has been specifically authorised in the signed contract (or other required
documentation of the engagement) between the Company and the Third Party, or has
otherwise received appropriate documented approval.

You must not Give any Payments for Voluntary or Incidental Activities to any
Third Party.

10.3 Our Interactions and engagements with External Stakeholders and Patients
must at all times be professional exchanges, designed to enhance the practice of
medicine, to benefit Patients, or to fulfill a genuine business need.

In no circumstances may the engagement of an External Stakeholder or Patient be
used as a means to gain access or to disguise Promotional Activities, or create
an appearance of doing so.

10.4 To the extent appropriate, Business Units must establish adequate Relevant
Procedures to mitigate the risk of actual or apparent improper influence over
individual External Stakeholders engaged to provide Services, and for monitoring
compliance.

To the extent appropriate, Business Units must establish Relevant Procedures
that include Fair Market Value guidelines, as well as limits on aggregate
compensation provided to individual External Stakeholders and limits on
frequency of engagement of individual External Stakeholders. The scope of such
guidelines and limits ultimately established will vary, based upon locality
and/or function. In developing Fair Market Value guidelines, these Business
Units must consider local established compensation levels, varying levels of
expertise and/or prominence of Third Parties, varying types and durations of
Services to be provided, and the spirit and principles of this Policy.

Third Parties must be paid compensation consistent with and no greater than Fair
Market Value, taking into account individual qualifications, experience, ability
and reputation, and only for the Services actually provided, consistent with the
terms of the engagement.

To the extent appropriate, Business Units must establish Relevant Procedures to
enable the Company to satisfy transparency obligations, with respect to payments
made to External Stakeholders.

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10.5 Prior to the selection and engagement of a Third Party, Engagement Owners
must conduct appropriate and proportionate risk assessments, as well as
associated, due diligence procedures (if necessary), according to Relevant
Procedures. Engagement Owners must take these steps to ensure that the Third
Party’s reputation and conduct relating to the execution of the engagement are
consistent with the Company’s ethical standards, with respect to all relevant
areas of risk.

To the extent appropriate, Business Units must establish Relevant Procedures to
guide Engagement Owners on how to assess, develop, communicate, implement and
enforce required compliance expectations for Third Parties. Required compliance
expectations will vary, based upon the nature of the Third Party, the Services
to be provided and the nature of the associated risks. Based upon the risk
assessment and outcomes for a particular Third Party, Engagement Owners may be
required to implement one or more of the following actions with respect to that
Third Party:

a) improvement plans or action plans;

b) monitoring or auditing requirements;

c) contractual obligations, including written assurances or commitments by the
Third Party;

d) provision of Global Policies, Global Standards, Relevant Procedures or other
reference materials, and/or associated training;

e) prior review of the engagement or aspects of the engagement or Services from
the relevant Legal and/or Compliance partner; and/or

f) other actions to mitigate identified areas of risk, such as contractual risk
mitigation clauses.

At a minimum, Engagement Owners must not engage a Third Party where it is known,
or where there is a reason to believe, that the Third Party has Given or
Received Bribes, unless the Engagement Owner has documented his/her satisfaction
with all of the following, in consultation with the relevant Legal and/or
Compliance partner:

a) the actions and improvements undertaken by the Third Party to remediate the
concerns and/or behaviour;

b) the current level of compliance by the Third Party; and

c) evidence of the Third Party’s ability to provide strong governance and
monitoring and to prevent future occurrences of such concerns and/or behaviour.

Engagement Owners, in consultation with an appropriately senior level of
management, must periodically reassess existing Third Party relationships,
following the required timeframes outlined in the Relevant Procedures, and
taking into account any unanticipated changes in the conduct, reputation or
risks related to the particular Third Party.

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10.6 See Section 2 of this Policy for further requirements on Engaging Third
Parties. Engagement Owners must also refer to the Global Standard on Engaging
Third Parties for further requirements, prior to entering into any engagement
with a Third Party.

11. PROMOTIONAL & NON-PROMOTIONAL ACTIVITIES & MATERIALS

11.1 A key part of Our business is to provide information about Company Products
and, where and when appropriate, to Promote their use. Promotional and
Non-Promotional Activities and Materials must always be accurate, fair and
balanced and not misleading in their content.

The Company has a duty to support the safe and effective use of Company
Products. While the Company cannot provide medical advice to External
Stakeholders or Patients, the Company may engage in Promotional and
Non-Promotional Activities where this is appropriate and permitted by local law.
For example, Promotional and Non-Promotional Activities directed to Patients
(i.e., “direct to consumer” activities) may only be undertaken where this is
permitted by local law.

Our activities must never undermine the relationship between HCPs and their
Patients. All Promotional and Non-Promotional Activities and Materials directed
to HCPs or Patients must therefore support HCPPatient Interactions and must
allow the therapeutic value of Company Products to be assessed by HCPs in the
interest of Patient care.

Promotional and Non-Promotional Materials about Company Products directed to
Patients must be understandable, taking into account varying levels of education
between and within populations. These Materials must be educational, scientific
and balanced, and should encourage the Patient to seek further information from
the appropriate HCP.

The Company may display Promotional or Non-Promotional exhibits, either in
conjunction with a Meeting or as a stand-alone activity, according to the
requirements included in Relevant Procedures. See the Global Standard on
Meetings for further requirements on exhibits (with or without a Meeting).

11.2 The Company must only Promote Company Products once the time is right to do
so (which will never be before the Company Product or Use has received the
necessary Authorisation), and only consistent with the approved labeling.

Promotional Activities and Promotional Materials must meet all of the following
requirements:

a) They must provide a fair balance between a Company Product’s benefits and its
risks or limitations. They must not exaggerate the benefits or downplay the
risks or limitations;

b) They must not mislead by distortion, exaggeration, undue emphasis, omission
or in any other way, and must not involve false or unapproved statements about
other companies’ products. Company Products must only be Promoted on their own
proven merits; and

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c) They must be capable of substantiation by reference to the approved labeling
or scientific evidence consistent with the approved labeling, and must not
involve discussions of Unauthorised Company Products or Uses.

Representatives and other Employees in customer-facing roles (e.g., public
relations, telemarketing, Marketing, Medical) must be trained as appropriate to
their role and must do all of the following in an accurate, responsible manner:

a) They must possess sufficient Company Product and disease area knowledge to
present information to External Stakeholders or Patients, as appropriate to
their role; and

b) They must be able to recognise inquiries regarding Unauthorised Company
Products or Uses and refer these inquiries to Scientifically Trained Personnel.

All training and educational materials must be approved through the Applicable
Internal Review Procedures.

Representatives and other Employees in customer-facing roles must have available
a copy of the current, approved labeling for each Company Product or Use
discussion they initiate with External Stakeholders.

Any revisions to the approved labeling must be communicated to Representatives
and other relevant customer-facing Employees as soon as reasonably possible.

Promotional Activities that are directed to External Stakeholders must be
confined to those individuals who are recognised practitioners in the area of
medicine concerning Authorised Company Products or Uses.

Promotional Activities and Promotional Materials must not be directed to
External Stakeholders who have requested that they not be sent such information.

11.3 Non-Promotional Activities and Materials (including those regarding disease
awareness programs) must not be used to Promote Company Products.
Non-Promotional Activities and Materials must be presented in an objective,
balanced manner, and must be scientific in tone, language, appearance and
intent.

Where local law allows the Company to respond to Company Product-related
questions from Patients, any such response may only be made by Scientifically
Trained Personnel or other specifically authorised Employee or Third Party,
according to Relevant Procedures. Patients communicating with the Company must
not be given medical advice, but must instead be referred to their HCP.

Specifically authorised Employees are permitted to proactively issue press
releases or other Non-Promotional Materials, such as those relating to financial
or investor information.

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Scientifically Trained Personnel are permitted to proactively present scientific
data or findings regarding Authorised or Unauthorised Company Products or Uses
with a view to generating further scientific insight, supporting the medical
community in learning about scientific/medical progress or sharing information
on current medical practice, such as at scientific congresses or similar events.

All inquiries concerning Unauthorised Company Products or Uses (whether from
External Stakeholders or Patients) must be referred to Scientifically Trained
Personnel. All responses to such inquiries, either oral or written, must then
come directly and only from such Scientifically Trained Personnel, and must meet
all of the following requirements:

a) Information must only be provided in response to unsolicited inquiries;

b) Information must be accompanied by the approved labeling, as applicable;

c) All responses must be limited to the scope of the inquiry and must provide
data which are appropriate to the source of the inquiry; and

d) All responses must contain (as relevant) a statement that the information
requested involves an Unauthorised Company Product or Use and that the Company
does not recommend Unauthorised Uses of the Company Product.

11.4 Promotional Materials and Non-Promotional Materials must be approved
through the Applicable Internal Review Procedures. Any modification to approved
Promotional or Non-Promotional Materials must also be approved through the
Applicable Internal Review Procedures.

You must not create, use or provide “home-made” or other unapproved Promotional
or Non-Promotional Materials on any topic. You must not alter any approved
Promotional or Non-Promotional Materials in any way, unless such creation or
alteration is for the express purpose of submitting these Materials for review
and approval.

Promotional and Non-Promotional Materials must be assigned an expiration date
upon approval, must be monitored for expiration date and must not be used after
the expiration date specified in the original approval, unless they are formally
re-approved through the Applicable Internal Review Procedures.

Promotional and Non-Promotional Materials must be accompanied by the approved
labeling where applicable, as required by Relevant Procedures.

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12. PRE-AUTHORISATION ACTIVITIES & MATERIALS

12.1 It is permissible to engage in Pre-Authorisation Activities (i.e.,
Profiling, Market Access and Pre-Authorisation Training activities), and to use
materials supporting such activities, to prepare for a successful commercial
launch of a Company Product or Use. Pre-Authorisation Activities must not be
used to disguise Pre-Authorisation Company Product Promotion, or create an
appearance of doing so.

Materials used for Pre-Authorisation Activities must be approved through the
Applicable Internal Review Procedures.

12.2 Relevant Employees (e.g., Employees in the Marketing, Medical or Sales
functions) and specifically authorised Third Parties may Profile customers prior
to Authorisation of a new Company Product or Use, to assist in segmentation and
targeting activities.

Profiling Activities may only be conducted if all of the following requirements
are met:

a) Employees engaging in Profiling must use materials (e.g., scripts) that have
been approved through the Applicable Internal Review Procedures;

b) These materials must be structured to allow for a brief conversation to
collect broad information about an External Stakeholder’s involvement in a
disease area, such as treatments and classes used (e.g., “What classes do you
use to treat this disease state?”), as well as their needs and the needs of
their Patients;

c) These materials must contain clear instructions on proper execution. These
materials must contain a clear, prominent prohibition against engaging in
Promotional Activities about the new Company Product or Use during a Profiling
conversation;

d) These materials must not contain targeted questions that are specific or
unique to a Company Product or Use;

e) If asked by the External Stakeholder about the purpose of the Employee’s
questions, Employees may objectively state that the Company has submitted a
Company Product or Use for regulatory Authorisation. Employees must not
proactively discuss the Company Product or Use in any further detail; and

f) In the event that the External Stakeholder asks for more details about the
Company Product or Use during a Profiling discussion, Employees (other than
those in the Medical function) may provide appropriate contact information for
the External Stakeholder to submit his/her own request for such information
(i.e., a “professional information request”), but such Employees must not
directly respond to the request or submit the request on behalf of the External
Stakeholder. Employees in the Medical function may directly respond to the
request and may submit a professional information request on behalf of the
External Stakeholder.

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During, and in support of, internal Company segmentation and targeting
activities, relevant Employees may share existing knowledge and review and share
prescribing data and other Company-purchased or publicly available information.

For the avoidance of doubt, Profiling activities are also permitted after
Authorisation of a new Company Product or Use.

12.3 Relevant Employees other than Representatives or their first line managers
(e.g., Employees in the Market Access or Medical functions) and specifically
authorised Third Parties may perform Market Access activities prior to
Authorisation of a new Company Product or Use, by providing Company Product or
relevant disease area information to Healthcare Organisations (“HCOs”) (i.e.,
payers) or Public Officials to support regulatory Authorisation, pricing or
reimbursement discussions.

For the avoidance of doubt, Market Access activities are also permitted after
Authorisation of a new Company Product or Use.

12.4 Pre-Authorisation Training on Unauthorised Company Products or Uses may be
initiated as necessary to allow for sufficient time to study and understand the
new information presented regarding the Company Product or Use, disease area,
disease management, External Stakeholder and Patient needs and/or the current
market, including the current state of medical practice, competitors and
existing therapies, and treatment protocols and Guidelines.

In making the determination of the timing and sequencing of Pre-Authorisation
Training for a particular new Company Product or Use (as a guideline, no longer
than 60 days before the expected Authorisation date), the Reviewer must seek
input from Employees in the Medical, Training, Commercial, Compliance and/or
Legal functions (“contributing functions”), as applicable, and must take into
account all of the following considerations:

a) whether the training will involve a new or familiar disease area;

b) whether the training will involve an Unauthorised Company Product or an
Unauthorised Use of an Authorised Company Product;

c) the likelihood of receiving significant changes and comments to the proposed
labeling submitted to the regulatory agency responsible for Authorisation;

d) the risks of pre-Authorisation Promotion arising from providing training on
Unauthorised Company Products or Uses and/or Promotional messages; and

e) other factors deemed relevant to the particular proposed training by the
Reviewer and/or contributing functions, who are evaluating the training need and
the associated risks.

All Pre-Authorisation Training materials must be marked with a clear, prominent,
appropriate disclaimer stating that the material is strictly for internal
purposes only (e.g., “For Internal Use

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Only”). These materials may include information on Unauthorised Company Products
or Uses or relevant disease areas, and may include relevant reprints. These
materials, or the information they contain, must not be shown, discussed, or
distributed outside the Company, except where an appropriate Third Party must
also be trained (e.g., a contract sales force or sales force of a co-promotional
partner).

After the relevant Authorisation has been obtained, information included in
Pre-Authorisation Training materials that is appropriate for discussion with
External Stakeholders or Patients may be included in

Promotional and/or Non-Promotional Materials specifically designed and approved
for those purposes.

13. NON-INTERVENTIONAL STUDIES

13.1 Non-Interventional Studies (“NISs”) must address a scientifically and
medically valid question to which the Company needs the answer.

These may include: the effectiveness and/or safety of a Company Product, medical
practice and drug utilisation characterisation, disease epidemiology and
clinical epidemiology, burden of disease (e.g., costs and quality of life) or
other Patient-reported outcomes, and compliance/adherence to a therapeutic
regimen.

13.2 The Company must not be involved in the decision to place a particular
Patient on a specific Company Product. That decision is made solely by the
Patient’s HCP.

An NIS must not be used to induce the use or prescription of a Company Product
or to train HCPs on the use of a particular therapy.

Patients must not be given a Company Product or switched to a Company Product
for the purpose of taking part in the study.

13.3 NISs must be observational in nature and the collected data must undergo a
formal analysis by the Company or by a Third Party on the Company’s behalf.

Additional diagnostic or monitoring procedures must not be applied to the
Patients, and epidemiological methods must be used for the analysis of collected
data.

13.4 See Section 2 of this Policy for further requirements on NISs. Employees
must also refer to the Relevant Procedures (i.e., International Procedures) for
further requirements.

All NISs must be registered and their results posted according to the
requirements of the Relevant Procedures.

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The decision to conduct an NIS and the selection, engagement and payment of NIS
investigators must meet all of the relevant requirements of Section 10 of this
Policy and the Global Standard on Engaging Third Parties.

Support for NISs may be Given by specifically authorised Third Parties on behalf
of the Company according to the Relevant Procedures.

14. INVESTIGATOR SPONSORED STUDIES

14.1 The Company recognises the importance of Investigator Sponsored Studies
(“ISSs”) in expanding scientific knowledge related to potential Uses of Company
Products.

An ISS may be conducted with Authorised or Unauthorised Company Products or
Uses.

All ISSs supported by the Company must be consistent with the research strategy
for the relevant Company Product.

14.2 The Company may provide support for an ISS, but must not be considered to
be the sponsor or to have any partial sponsorship role in the study in
accordance with local law.

The decision to provide support for an ISS must be based on whether the study
expands scientific knowledge related to potential Uses of Company Products
and/or associated disease area(s) through a properly conducted independent
clinical study that will result in the publication of meaningful new data.

14.3 See Section 2 of this Policy for further requirements on ISSs. Employees
must also refer to the Relevant Procedures (i.e., International Procedures) for
further requirements.

A contract approved through the Applicable Internal Review Procedures must be
negotiated and signed by authorised representatives of the Company and the
sponsor and, as applicable, the investigator, prior to study initiation.

The level of financial support that may be provided will vary among countries.
It must always be consistent with Fair Market Value for the activities to be
conducted as part of the clinical trial, and payments must be milestone-driven.

The Company must not provide Company Product Samples for use in ISSs.

Support for ISSs may be Given by specifically authorised Third Parties on behalf
of the Company according to the Relevant Procedures.

GLOSSARY

Advisory Boards refers to internal Meetings organised by the Company where the
Company engages External Stakeholders (i.e., “Advisors”) to provide the Company
with independent advice and input within their area of expertise.

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Advisors refers to the definition provided within the definition of Advisory
Boards.

Applicable Internal Review Procedures refers to the review and approval
requirements for Interactions and supporting materials, as set out in Relevant
Procedures. These requirements include, but are not limited to, review and
approval by Nominated Signatories, Scientifically Trained Personnel, the Legal
Department, other specialist functions (e.g., Procurement) or line managers, as
appropriate (i.e., “Reviewers”). Reviewers must take into account the substance,
as well as the intended purpose and audience, when approving Interactions or
supporting materials, and approval must be obtained in advance of any
Interaction or use of supporting materials.

Authorisation or Authorised refers to approval of a Company Product or Use by
the relevant local regulatory agency, to permit entry into the local market or
to permit inclusion into the local approved labeling.

Bribe or Bribery refers to Giving or Receiving of something of value that is
intended or could be seen as an inducement or reward for improper behaviour
(i.e., behaviour that is dishonest or illegal or a breach of duty of
impartiality, trust or good faith), to influence any official act or decision,
or to obtain or retain business, favourable treatment or other advantage or
benefit. Giving or Receiving of Bribes is a wellrecognised form of corruption
(collectively referred to as “improper influence” through this Policy).

Business Unit refers to a distinct section of the Company, such as a
consolidated legal entity, a local marketing organisation, a Senior Executive
Team (“SET”) function, a department or operating entity within a SET function,
or, in some cases, a cross-functional unit comprising Employees with common
responsibilities.

Community Investment Contributions refers to certain charitable Donations,
Sponsorships or Partnerships Given by the Company to non-profit organisations
that meet the relevant criteria described in the Global Standard on
Contributions and the Global Procedure and Guidance Community Investment.

Company or Our refers to AstraZeneca PLC and its consolidated legal entities
worldwide, including MedImmune.

Company Product refers to any pharmaceutical or biological product or medical
device that is developed and/or marketed by the Company, including
investigational products/devices and co-promoted products/devices. For purposes
of this Policy, references to Company Products include both Authorised and
Unauthorised Company Products, unless specifically noted.

Conflicts of Interest refers to situations where personal, financial or other
interests, activities or associations outside of the Company may influence or
compromise, or could be seen to influence or compromise, the professional duties
and decisions of an Employee or Third Party providing Services.

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Contributions refers to financial or non-financial support (e.g., funds or
in-kind assistance, such as resources, facilities or Employee time) Given by the
Company to a Third Party. Contributions may be classified as either Donations,
Sponsorships or Partnerships.

Cultural Courtesy Gift refers to a personal Gift traditionally given to
acknowledge a significant national, cultural or religious holiday or event.

Donations refers to the type of Contributions Given by the Company to a
non-profit or Public Sector Organisation, that may or may not be for a
designated pre-defined initiative.

Employee or You(r) refers to all Company full-time and part-time directors,
officers, employees and temporary staff worldwide.

Engagement Owners refers to Employees responsible for engaging with and managing
the Services provided by a Third Party.

External Stakeholders refers to the category of Third Parties who are external
customers and other relevant stakeholders, including Healthcare Professionals
(“HCPs”) and Healthcare Organisations (“HCOs”), Scientifically Trained Personnel
engaged by the Company to provide Services, Public Officials, Patient Groups and
other relevant public and private organisations and groups.

A Facilitation Payment (or “grease” payment) is an unofficial payment or
anything else of value Given to Public Officials (including HCPs and other
individuals employed by Public Sector Organisations) to secure or speed up
routine actions that the recipient has a duty to perform. Examples include
additional payments required to issue permits or licences, speed passage through
immigration controls and release goods held at port or in customs.

Fair Market Value refers to the amount that a service or item would be worth to
a typical buyer who is under no duty to purchase and who receives no special
advantage. Fair Market Value is determined by the home country of the relevant
service provider (who receives payment for the service) or relevant buyer of the
item.

Fellowships and Preceptorships refer to programmes conducted at host
institutions and designed to provide basic training (i.e., training necessary to
obtain a degree or licence) or advanced education to HCPs or scientists in a
particular specialty, therapeutic area or field of research.

Gift refers to an Item of Value that is provided as a mark of appreciation,
commemoration or friendship.

Give, Giving or Given means to directly or indirectly offer, promise or give, or
to authorise such actions.

Global Policies refers to the mandatory documents that support the Company’s
Code of Conduct by setting out the compliance commitments of the Company and the
key principles to be followed to meet those commitments.

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Global Standards refers to the mandatory documents that support the Global
Policies by describing the compliance rules to be followed to deliver the intent
stated in the Global Policies or in the Company’s Code of Conduct.

Guidelines refers to any of the following materials and may or may not relate to
a specific disease state: practice guidelines, treatment guidelines, medication
algorithms, disease definitions or Research & Development quality standards.
Guidelines are not intended to refer to treatment guidelines or protocols
developed by HCOs, where such development is essential to the business of the
HCO (such as a formulary or benefit administrator), or those developed by HCP
practices.

Healthcare Professionals (“HCPs”) and Healthcare Organisations (“HCOs”) refer to
individuals or organisations, respectively, who may or do prescribe, administer,
recommend, purchase, pay for, reimburse, authorise, approve or supply any
Company Product or service, including any members of the medical, dental,
pharmacy or nursing professions, and relevant associated administrative staff;
and/or hospitals and other care organisations, health plans, health insurers,
managed care organisations, pharmacies, formulary or benefit administrators and
clinical research organisations, and relevant staff at such entities.

Hospitality refers to Meals, travel/accommodation, and other directly related,
incidental expenses, as well as invitations or tickets to social or
entertainment events. Entertainment events include sporting, theatre, music or
recreational events.

Interactions refers to the business and personal interactions and activities
described in this Policy.

Interacts refers to the conduct of an Interaction.

Investigator Sponsored Study (ISS) refers to a clinical study that is
independently initiated, designed and conducted by an external investigator (who
assumes both the sponsor and principal investigator role) or medical
institution, collaborative research group or academic research organisation
(which assumes the sponsor role and appoints principal investigator(s) for the
study). For purposes of this Policy, sponsor/investigator is used as a generic
term for both situations described above.

Item of Medical Utility refers to an Item of Value primarily designed to educate
External Stakeholders or Patients or help External Stakeholders educate Patients
about disease management in disease state areas relevant to Authorised Company
Products or Uses.

Items of Value refers to Gifts, Items of Medical Utility, items used to assist
in screening or diagnosis of Patients, items linked to the safe and effective
administration of Company Products, logistical items, Samples (including Samples
vouchers or coupons), awards and Patient Programmes.

Market Access refers to discussions with HCOs (i.e., payers) or Public Officials
about regulatory Authorisation, pricing or reimbursement decisions.

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Market Research refers to the systematic gathering and interpretation of
quantitative or qualitative data on the market environment from External
Stakeholders or Patients using statistical and analytical methods to gain
insight and support decision-making. It does not include the gathering and
interpretation of “real world evidence” or Company-purchased HCP-level data.

Meals refers to food and/or beverages.

Meeting refers to a planned gathering of External Stakeholders, which the
Company organises or supports, either financially or non-financially.
Non-financial support includes in-kind assistance, such as resources, facilities
or Employee time. Meetings may be for an internal Employee audience, or for an
external audience of External Stakeholders and may be held in-person or
virtually.

Non-Interventional Study (NIS) refers, in general terms, to a study where the
assignment of the Patient to a particular therapeutic strategy is not decided in
advance by a study protocol but falls within the HCP’s current practice, and the
prescription of the Company Product is clearly separated from the decision to
include the Patient in the study.

Non-Promotional Activity refers to any activity that is not a Promotional
Activity that is intended to provide scientific or educational information about
Company Products, relevant disease areas or health and medicines generally.
Non-Promotional Activities may be oral or written and may be conducted through
any medium, including the Internet. Non-Promotional Activities may take a number
of forms, including, but not limited to, leaflets provided with Company
Products, point of sale information, information regarding disease awareness
programmes, responses to queries from External Stakeholders or Patients,
information provided to inform the development of Guidelines or other
information contributing to scientific exchange.

Non-Promotional Materials refers to materials intended to be used during
Non-Promotional Activities or to support Non-Promotional Activities.

Our or Company refers to AstraZeneca PLC and its consolidated legal entities
worldwide, including MedImmune.

Other Third Parties refers to the category of Third Parties who are not External
Stakeholders or Patients, including, but not limited to, the media, suppliers,
distributors, agents and joint venture, co-promotion, research and licensing
partners.

Partnerships refers to the type of Contributions Given by the Company in
collaboration with a non-profit, for-profit or Public Sector Organisation for a
pre-defined initiative, involving substantive, active Company participation and
resulting in the delivery of specific, measurable outcomes. For purposes of this
Policy, Partnerships do not include research or commercial collaborations aimed
at the development or marketing of Company Products or services for the
Company’s benefit.

Patient Groups refers to non-profit organisations formally representing the
needs of Patients, theirfamilies and other caregivers.

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Patient Programmes refers to Items of Value, specifically vouchers, rebates,
coupons, co-pay assistance cards, motivational information and other programmes
and materials designed to increase access and affordability of Company Products
or to enhance therapy compliance.

Patients refers to the category of Third Parties who are members of the general
public and who use or may use Company Products.

Payments for Voluntary or Incidental Activities refers to any compensation or
expense reimbursement Given to an individual or organisation as a “thank you”
for voluntary activities or for activities that are not necessary to address a
genuine business need. They do not include payments made to Third Parties for
contracted Services that address a genuine business need.

Policy refers to this AstraZeneca Global Policy on Ethical Interactions.

Political Activities refers to attendance or participation in public policy or
other political activities, including participation in political conventions or
fundraising events for Political Organisations or individual Public Officials
and their causes.

Political Organisations refers to political parties and their employees,
Political Action Committees (“PACs”) and other political organisations.
Political Support is distinct from Company Contributions to Public Sector
Organisations (See Section 5), as well as payments to Public Officials or Public
Sector Organisations (See Sections 7 and 10).

Political Support refers to financial or non-financial support (e.g., funds or
in-kind assistance, such as resources, facilities or Employee time) Given to
Political Organisations or individual Public Officials and their causes.

Pre-Authorisation Activities refers to Profiling, Market Access and
Pre-Authorisation Training activities undertaken by Employees in preparation for
Authorisation of a new Company Product or Use.

Pre-Authorisation Training refers to Company-provided education to
Representatives and/or their first line managers in preparation for
Authorisation of a new Company Product or Use.

Preceptorships and Fellowships refer to programmes conducted at host
institutions and designed to provide basic training (i.e., training necessary to
obtain a degree or licence) or advanced education to HCPs or scientists in a
particular specialty, therapeutic area or field of research.

Presentation refers to each segment of a Meeting, where a distinct speaker is
used and/or distinct topic is discussed.

Presentation Materials refers to all materials intended to be shown and/or
distributed to the speaker or audience before, during or after a Presentation,
including but not limited to speaker briefing documents, written summaries of
Presentation objectives, slides and reference documents.

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Profiling (also known as “disease insight visits”) refers to discussions with
External Stakeholders to gain an understanding of their involvement in a disease
area, including therapeutic options, medical gaps, External Stakeholder needs or
the needs of Patients. For the avoidance of doubt, Profiling is not considered
Market Research.

Promote, Promotion or Promotional refers to the conduct of Promotional
Activities.

Promotional Activity refers to any activity that is intended or could be seen to
Promote the prescription, administration, recommendation, purchase, payment,
reimbursement, authorisation, approval, supply or use of Company Products or
services. Promotional Activities may be oral or written and may be conducted
through any medium, including the Internet.

Promotional Materials refers to materials intended to be used during Promotional
Activities or to support Promotional Activities.

Promotional Speaker Programmes refers to Promotional Meetings organised by the
Company to Promote Authorised Company Products or Uses, where the Company
engages External Stakeholders

(i.e., “Promotional Speakers”) to speak to other External Stakeholders on behalf
of the Company about such topics.

Promotional Speakers refers to the definition provided within the definition of
Promotional Speaker Programmes.

Public Official refers to an individual who:

●

Holds a legislative, administrative or judicial position of any kind, whether
appointed or elected, or is a candidate for such a position, or

●

Exercises a public function for a country or territory of a country, or for any
Public Sector Organisation of a country or territory, at the national, regional
or local level,

●

Acts as an official or agent of an international Public Sector Organisation, or

●

Is any other employee (including HCPs) of a Public Sector Organisation.

Public Sector Organisation refers to an agency, enterprise, or other entity of a
government that sets or administers public policy or exercises executive,
political and/or sovereign power through customs, institutions and laws within a
country or territory of a country, at the national, regional or local level. It
also includes state-owned and state-controlled entities, such as a state-owned
or state-controlled hospital, university, energy company, telecommunications
company or other similar state-owned or statecontrolled enterprises.

Receive, Receiving or Received means to directly or indirectly solicit, agree to
receive or accept, or to authorise such actions.

Relevant Procedures refers to the written local and/or functional policies,
standards, procedures and guidelines that contain details, processes and
controls for compliance with this Policy and the supporting Global Standards.

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Representatives refers to Employees who are members of any Commercial channel
who Promote Company Products directly to External Stakeholders. Representatives
may be referred to as sales representatives, service team associates, inside
sales agents, medical representatives or other titles, depending upon the
relevant local marketing organisation. Representatives include any Third Parties
fulfilling such responsibilities on the Company’s behalf (i.e., a contract sales
force). Representatives do not include other Employees, such as those performing
marketing or market access activities.

Reviewers refers to the definition provided within the definition of Applicable
Internal Review Procedures.

Sample refers to an Item of Value, specifically a unit of pharmaceutical Company
Product that is not to be sold but is provided free of charge to an HCP to allow
the HCP and appropriate Patients to determine tolerability and effectiveness of
the Company Product.

Scientifically Trained Personnel refers to individuals employed or engaged by
the Company who are highly-trained experts, who have relevant, specialised
scientific and/or medical knowledge and whose responsibilities include the
provision of scientific and/or medical information. This excludes anyone in the
Sales, Marketing or other non-Medical Commercial functions, even if they have
scientific or medical training or backgrounds.

Section refers to Sections 1 through 14 of this Policy, listed in the Table of
Contents. Each Section covers a category of Interactions.

Services refers to the activities performed by a Third Party engaged by the
Company. Services include activities performed on behalf of the Company, goods,
services or information provided to the Company, or the activities performed in
collaboration with the Company.

Sponsorships refers to the type of Contributions Given by the Company to a
non-profit, for-profit or Public Sector Organisation for a pre-defined
initiative, where the Company’s name is associated with the initiative and/or
the Company receives other substantial recognition for the Sponsorship.

Sympathy Gift refers to a personal Gift to express sympathy for bereavement or
serious illness of the recipient or immediate family member.

Third Party(ies) refers to any person or organisation who is not the Company or
an Employee, with whom Employees Interact. The various types of Third Parties
are categorised as either External Stakeholders, Patients, or Other Third
Parties. Where a Third Party fits into more than one category, the more
restrictive rules apply.

Uses refers to the indications, dosing, populations and other uses of Company
Products. For purposes of this Policy, references to Uses include both
Authorised and Unauthorised Uses of Company Products, unless specifically noted.

Unauthorised refers to a Company Product or Use that has not yet received
Authorisation from the relevant local regulatory agency. An Unauthorised Company
Product may also be referred to

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as “investigational.” An Unauthorised Use (i.e., an “off-label use”) is
inconsistent with the local approved labeling for a Company Product.

Voluntary or Incidental Activities refers to any voluntary activities or
activities that are not necessary to address a genuine business need.

You(r) or Employee refers to all Company full-time and part-time directors,
officers, employees and temporary staff worldwide.

REFERENCES

Global Standard on Items of Value and Hospitality

http://portalapps.is.astrazeneca.net/azgard-components/ldms-documents/Global_Compliance/effective/Global%20Standard/LDMS_001_00145832.pdf

Global Standard on Contributions

http://portalapps.is.astrazeneca.net/azgard-components/ldms-documents/Global_Compliance/effective/Global%20Standard/LDMS_001_00145831.pdf

Global Procedure and Guidance Community Investment

http://portalapps.is.astrazeneca.net/azgard-components/ldms-documents/Global_Compliance/effective/Procedure/LDMS_001_00146359.pdf

Global Guidance for Product Donations

http://portalapps.is.astrazeneca.net/azgard-components/ldms-documents/Global_Compliance/Active/Guidance%20Materials/LDMS_001_00146361.pdf

Global Standard on Meetings

http://portalapps.is.astrazeneca.net/azgard-components/ldms-documents/Global_Compliance/effective/Global%20Standard/LDMS_001_00145768.pdf

Global Standard on Engaging Third Parties

http://portalapps.is.astrazeneca.net/azgard-components/ldms-documents/Global_Compliance/effective/Global%20Standard/LDMS_001_00145830.pdf

 

 

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Exhibit G

Initial Members of the JSC

AstraZeneca

Fouzia Laghrissi Thode, Vice President, Global Product Portfolio Strategy

Elisabeth Björk, Global Product Vice President, Global Medicines Development

Howard Hutchinson, Vice President for Product Licensing, Global Medicines
Development

Peter Honig, VP Global Regulatory Affairs, Global Regulatory Affairs

David Snow, President, China & Hong Kong, Global Commercial

AstraZeneca Secretariat: Joseph McCullough

FibroGen

Frank Valone

Peony Yu

Al Lin

Michael Lowenstein

Chris Chung

FibroGen Secretariat: Kirara Tsuboi

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Schedule G (a)

Until the date when the JDC has been formed, the JSC delegates the following
responsibilities to the Core Joint Project Team.  Unless otherwise directed by
the JSC, the Core JPT shall:

(i)provide regular reports to the JSC regarding the development of the Product,
and discuss, prepare and submit to the JSC for approval annual and interim
amendments to the Development Plan (and the Development Budget) for each
Product;

(ii)discuss and manage the implementation of the Initial Development Plan;

(iii)discuss the audited final report from the Carcinogenicity Studies,
including whether or not a Technical Product Failure has occurred, and provide
input thereon to the JSC;

(iv)propose to the JSC particular studies to be conducted;

(v)create, propose for JSC review and approval, and implement the Development
Strategy for Development in the Territory and the design of all Clinical Trials
and Nonclinical Studies conducted under each Development Plan, including Phase 4
Clinical Trials;

(vi)create and propose the CMC related development plan for JSC review and
approval, and oversee any CMC related development activities according to the
plan, e.g. stability studies or packaging development, as well as other
activities to prepare for supply of drug substance and finished Product for
Commercialization, including to oversee the selection process for, and select
(pursuant to Section 6.4), a contract manufacturer to be used by FibroGen for
commercial supplies;

(vii)allocate budgeted resources and determine priorities for each Clinical
Trial and Nonclinical Study under each Development Plan, including Phase 4
Clinical Trials;

(viii)supervise, with regular oversight by the JSC, the conduct of all Clinical
Trials and Nonclinical Studies under each Development Plan, including Phase 4
Clinical Trials;

(ix)endorse the selection of Third Party contractors to conduct Clinical Trials
of Products;

(x)facilitate, with regular oversight by the JSC, the flow of Information
between the Parties with respect to the Development of Products, including
Development Data and Astellas Data pursuant to Section 3.10, as well as any
other Information related to the Astellas Collaboration that has a material
impact on AstraZeneca’s rights under this Agreement;

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(xi)discuss the priority of life cycle management Development of Products for
other indications and propose any such indications to the JSC;

(xii)propose to the JSC for approval allocation of primary responsibility as
between the Parties for tasks relating to Development of Products where not
already specified in the Development Plan;

(xiii)discuss the requirements for Regulatory Approval in the Territory and
oversee and coordinate regulatory matters with respect to Products in the
Territory, including to review and approve material regulatory filings (other
than the filing of an NDA in the U.S., which shall be approved by the JSC) prior
to submission thereof;

(xiv)propose to the JSC for approval and implement a publication strategy for
publications and presentations related to Products in the Territory and review
and approve all such publications in accordance with Section 12.5, provided that
the responsibilities under this subsection (xvi) with respect to a certain
Product shall transition from the JDC to the JCC following the first NDA
approval of such Product in the U.S., the more precise timing of such transition
to be mutually agreed by the Parties;

(xv)facilitate the flow of Information between the Parties with respect to
obtaining Regulatory Approval for Products; and

(xvi)perform such other functions as may be appropriate to further the purposes
of this Agreement, as directed by the JSC.

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Schedule G (b)

Until the date when the JCC has been formed, the JSC delegates the following
responsibilities to Core Joint Project Team.  Unless otherwise directed by the
JSC, the Core JPT shall:

(xvii)regularly report to the JSC regarding the Commercialization of the
Products, and discuss, prepare and submit for approval to the JSC the U.S.
Commercialization Plan for each Product in the U.S., including any amendments
thereto;

(xviii)coordinate the Commercialization activities of FibroGen and AstraZeneca
with respect to Products, including pre-launch and post-launch activities;

(xix)propose to the JSC for approval the allocation of primary responsibility as
between the Parties for tasks relating to Commercialization of Products in the
U.S.;

(xx)propose to the JSC for approval the amount of Product to be distributed free
of charge annually for regulatory or marketing purposes or
investigator-initiated trials (it being understood and agreed that neither Party
shall have the right to distribute the Product as samples except pursuant to
Section 5.7); and

(xxi)perform such other functions as appropriate to further the purposes of this
Agreement, as directed by the JSC.

 

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Exhibit H

FG-4592 Initial Development Plan

[ * ]

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[ * ]

 

[ * ]

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[ * ]

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[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

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[ * ]

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[ * ]

[ * ]

[ * ]

[ * ]

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Exhibit I

U.S. Co-Commercialization Terms

Unless the Parties agree in writing upon an alternate allocation of
responsibility, the Parties shall have the following rights and obligations with
respect to the operational responsibilities for the Commercialization of
Products in the U.S. under each U.S. Commercialization Plan, under the direction
of the JCC as specified in Section 2.4 and Article 5.  [ * ]

 

 

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Exhibit J

Development Supply Terms

The supply from FibroGen to AstraZeneca, or to FibroGen internally where
FibroGen has been assigned (either by the JDC or under the terms of the
Agreement) the lead responsibility for the conduct of a Clinical Trial for which
the supply is intended, shall include those GMP quantities of Product, and those
development activities, in either case, approved by the JDC.  As of the
Effective Date, the JDC has not been convened.  Therefore, the Parties have
agreed that the following provisions shall govern the manufacture and delivery
of the supplies necessary to conduct the Clinical Trials under the Development
Plan.

FibroGen shall manufacture and supply an appropriate amount (currently estimated
at up to approximately 3 million units of Product (i.e. 3 million tablets of
active drug) and approximately 1.5 million tablets of placebo) for the conduct
of the Phase 3 Clinical Trials sponsored by AstraZeneca as well as the amount
required to support FibroGen’s studies and regulatory submissions.  The Parties
shall agree upon more exact quantities as soon as possible.  Such unit numbers
shall include varying drug strengths for the Clinical Trials and shall be
delivered at least four (4) months ahead of the start of the Clinical Trials,
subject to Section 6.2.  

FibroGen shall continue its already started development of a solid formulation,
e.g. tablet, aimed at enabling attributes such as commercially viable shelf-life
and use of standard primary packages, a dosage unit size to enable an attractive
intake by patients as well as deemed possible to manufacture by conventional
manufacturing technology in a cost effective manner and that does not reduce the
clinical effectiveness or increase a hypothetical adverse event profile of the
Product.  FibroGen shall initiate in vivo testing as needed and according to
timelines agreed by the JDC.  

The supplies and activities set forth in this Exhibit J may be amended from time
to time by the JDC or the JSC.  

FibroGen shall report the progress of the items listed above to AstraZeneca’s
appointed Pharmaceutical Development contacts on a regular and reasonable basis.
FibroGen shall also consult AstraZeneca prior to making any critical decisions
with material impact on further development, e.g. choice of solid state form,
particle size control methodology, choice of excipients, process technology and
packaging materials, stability testing protocols, quality specifications and
analytical testing methodology, choice of starting materials and sourcing.

 

 

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Exhibit K

Main Terms for Supply Agreement and Quality Agreement

The Supply Agreement (“SA”) and Quality Agreement (“QA”) referenced at Section
6.3 of the Agreement shall contain the following main terms and
conditions.  Capitalized terms used but not defined in this Exhibit K shall have
the meaning ascribed to such terms in the Agreement.

Supply

•

Effective Date of SA/QA: The SA and the QA will provide for an effective date
which is earlier than the execution date, in case supply of Product is required
prior to execution of the SA and the QA.

•

Conflict:  In the event of a conflict between the Agreement and the SA or the
QA, the SA once executed will control with respect to supply matters, and the
QA, once executed, will control with respect to quality matters.

•

Forecasting, Ordering and Delivery: Terms relating to forecasting and ordering
shall be set forth in the SA.  The Parties shall agree and include in the SA, a
mechanism for defining the lead-times for all Products ordered by
AstraZeneca.  Delivery of Product shall be EXW INCOTERMS 2010 to an address
specified by AstraZeneca.  Title shall pass to AstraZeneca on delivery to
AstraZeneca or its designee.

•

Failure to Supply:  The SA will include remedies and other consequences for
supply failure (to be defined in the SA) including: (i) rights for AstraZeneca
to access relevant information in the possession of FibroGen and its affiliates
relating to the manufacturing processes for the Product; and (ii) rights for
AstraZeneca to contact FibroGen’s suppliers (including suppliers of the active
pharmaceutical ingredient for the Product), both (i) and (ii) to assess the
feasibility of (including contracting with) such suppliers manufacturing and
supplying the Product to AstraZeneca, solely in the event of a supply failure by
FibroGen.

•

Insurance and Risk:  The agreement will contain provisions requiring FibroGen to
maintain insurance coverage of the types and in the amounts typically carried by
providers of manufacturing services in the pharmaceutical or chemical area.
FibroGen shall bear the risk of loss of materials (including API) and Product
while within FibroGen’s or its subcontractor’s control.

•

Subcontractors:  FibroGen may engage subcontractors (“Subcontractors”) that meet
the quality standards agreed by the Parties.  No such subcontract shall release
FibroGen from any of its obligations under the SA or the QA except to the extent
such obligations are satisfactorily performed by such Subcontractor in
accordance with the SA and the QA.  To the extent that AstraZeneca has genuine
concerns and can demonstrate with reasonable documentation to FibroGen the basis
for its concern with respect to the performance of the

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work for which the Subcontractor is to be engaged, the choice of such
Subcontractor shall be subject to AstraZeneca’s approval.

•

Formulation:  In the event the Parties decide that AstraZeneca will carry out
formulation of the Product, such activities will be included in the SA and any
applicable terms will be added to the SA to account for AstraZeneca’s role in
the formulation activities.

•

Non-Conforming Product:  The agreement will contain provisions relating to the
determination and replacement of nonconforming product and the use of a Third
Party testing laboratory to resolve disputes relating to nonconforming product.

•

Shortfalls: The SA will include consequences relating to any failure or
inability to supply full quantities of Product in compliance with the applicable
product specifications ordered by AstraZeneca, including an obligation that in
the event of a shortage, FibroGen will allocate an amount of its remaining
manufacturing capacity in an equitable manner to be set forth in the Supply
Agreement.

•

Pricing and Payment:  The pricing provisions set out in Section 6.5 of the
Agreement shall be incorporated into the terms of the SA.  AstraZeneca shall pay
invoices in accordance with the terms set forth in the Agreement.

•

Legal and Regulatory Requirements:  Appropriate provisions shall be included in
the SA to ensure that each Party complies with all relevant local, national and
international legal or regulatory requirements and other relevant requirements
applicable to the manufacture, handing, transport and storage of all Products at
all times.

•

Governance:  The SA will include governance and reporting provisions specific to
the manufacturing activities, which governance provisions will be designed to
provide AstraZeneca transparency into the activities under such agreement,
including subcontracting and CMO arrangements, and to facilitate effective
management of the supply chain.

•

Health and Safety:  FibroGen shall be wholly accountable and liable for the
safety, health and environmental aspects of all work performed on its or any of
its subcontractor’s premises.

•

AstraZeneca Policies:  The SA will include provisions required to comply with
applicable AstraZeneca standard policies, including with respect to responsible
procurement, product security and waste handling.

•

Document Retention:  Appropriate provisions shall be included in the SA with
regard to maintaining appropriate documentation for patent and regulatory
purposes and in full compliance with all applicable laws.

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•

Technology Transfer:  The technology transfer provisions in the Agreement will
remain in effect during the term of the SA (and any post-expiration or
termination supply period, as described above in Section 13.6(e) or (g)), even
after the Agreement has terminated or expired.

•

Liability and Indemnity:  The SA will include provisions relating to liability
and indemnification that are consistent with the principles of allocation of
liability described in the Agreement.

•

Warranties:  FibroGen will be required to provide customary representations and
warranties within the SA, including (but not limited to) as to the following:

(a)that it has full power and authority, and has taken all necessary actions and
has obtained all necessary authorizations, licenses, consents and approvals
required, to execute and perform the SA, and

(b)that its retention as a supplier by AstraZeneca and its performance of the SA
do not, and shall not, breach any agreement with any other third party.

•

Generally:

 

o

The SA shall include such terms as are reasonable and customary for similar
supply agreements.

 

o

Each of the Parties agree and acknowledge that the SA will contain a number of
provisions which shall be consistent with provisions in the body of the
Agreement, including Confidentiality, Assignment, Governing Law and Dispute
Resolution.

Quality

•

General:  A Quality Agreement shall be negotiated in good faith between the
Parties and shall include all appropriate provisions as would normally be
contained in such an agreement. Any breach of the QA shall be deemed a breach of
the SA.

•

The QA shall include:

 

o

Notice to AstraZeneca of inspections by regulatory authorities and access to
such inspections

 

o

Notice to AstraZeneca of and access to all investigations concerning the
manufacture of Products

 

o

Provision by FibroGen of documentation required by AstraZeneca

 

o

Maintenance of a change control system which allows for the pre-approval of
major changes

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o

Rights for AstraZeneca to conduct quality audits on FibroGen or any
Subcontractor

 

o

Agreed procedures on a product recall

•

Each of the Parties agrees and acknowledges that the Products must satisfy
appropriate specifications and associated tests, details of which shall be set
out in the QA, and a mechanism for handling any defective products shall be
agreed and included in the QA.

 

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Exhibit L

Invoicing Requirements

Subject to any separate instructions to be agreed between the Parties regarding
payments to health care professionals or health care organizations in the
Territory, as required by applicable laws and regulations, invoices should be
sent to:

AstraZeneca AB

AstraZeneca R&D Mölndal

Att. Christina Wågestrand

CVGI iMed Strategy

431 83 Mölndal

Sweden

Invoices shall contain the following information:

 

a.

AstraZeneca’s Agreement ID: Elisabeth Björk, Global Product Vice President,
Global Medicines Development, ECHO Project ID 10007956

 

b.

the number and date of invoice

 

c.

the latest date of payment according to Agreement

 

d.

description of services

 

e.

name and address of FibroGen, Inc.

 

f.

FibroGen, Inc. VAT registration number or EIN/TaxID,

 

g.

AstraZeneca’s VAT registration number SE556011748201 (in EC),

 

h.

VAT rate (%), if any,

 

i.

taxable amount per VAT rate, if any,

 

j.

VAT amount, if any

 

k.

legal reference or explanation when VAT is excluded,

 

l.

invoice amount and currency,

 

m.

bank details, preferably IBAN code, otherwise account number and bank code, and

 

n.

SWIFT-address.

 

 

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Exhibit M

Patents that may be Extended

[ * ].

 

 

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Exhibit N

AstraZeneca and FIBROGEN COLLABORATE to develop and commercialiSe fg-4592, a
treatment FOR anaemia IN chronic kidney disease and end-stage renal disease

Collaboration to include US, China and selected other markets

31 July 2013

AstraZeneca and FibroGen today announced that they have entered into a strategic
collaboration to develop and commercialise FG-4592, a first-in-class oral
compound in late stage development for the treatment of anaemia associated with
chronic kidney disease (CKD) and end-stage renal disease (ESRD).

This broad collaboration focuses on the US, China and all major markets
excluding Japan, Europe, the Commonwealth of Independent States, the Middle East
and South Africa, which are covered by an existing agreement between FibroGen
and Astellas Pharma Inc. The AstraZeneca-FibroGen joint effort will be focused
on the development of FG-4592 to treat anaemia in CKD and ESRD, and may be
extended to other anaemia indications.

FG-4592 is a small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl
hydroxylase. HIF is a protein that responds to oxygen changes in the cellular
environment and meets the body’s demands for oxygen by inducing erythropoiesis,
the process by which red blood cells are produced. FG-4592 has the potential to
address the considerable unmet medical need for an effective treatment for
anaemia that offers the convenience of oral administration and an improved
safety profile as compared to current standards of care. At present, treatment
options involve a combination of injectable erythropoiesis-stimulating agents
(ESAs) and iron supplements. FG-4592 works through the body’s natural
oxygen-sensing and response system to help produce red blood cells. This can be
compared to the body’s natural response to conditions at high altitude, where
oxygen levels are low, which is to produce more red blood cells.

In Phase II clinical studies, FG‑4592 met its primary objective of demonstrating
anaemia correction in treatment-naïve CKD patients not on dialysis as well as
maintenance of haemoglobin levels and anaemia correction in patients on
dialysis. FG‑4592 has demonstrated this efficacy combined with an acceptable
safety profile in clinical trials, and has been shown to achieve anaemia
correction in the absence of intravenous iron supplementation.

The companies plan to undertake an extensive FG-4592 phase III development
programme for the US, and to initiate phase III trials in China, with
anticipated regulatory filings in China in 2015 and in the US in 2017.

AstraZeneca will pay FibroGen committed upfront and subsequent non-contingent
payments totalling $350 million, as well as potential future development related
milestone payments of up to $465 million, and potential future sales related
milestone payments in addition to tiered royalty

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payments on future sales on FG-4592 in the low 20% range. Additional development
milestones will be payable for any subsequent indications which the companies
choose to pursue. AstraZeneca will be responsible for the US commercialisation
of FG-4592, with FibroGen undertaking specified promotional activities in the
ESRD segment in this market. The companies will also co-commercialise FG-4592 in
China where FibroGen will be responsible for clinical trials, regulatory
matters, manufacturing and medical affairs, and AstraZeneca will oversee
promotional activities and commercial distribution.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “Our collaboration
with FibroGen on FG-4592 is an important addition to AstraZeneca’s growing
late-stage portfolio in cardiovascular and metabolic disease, one of our core
therapy areas. We know from our research into complications of renal disease
that anaemia continues to be a challenge for patients with chronic kidney
disease, due in part to the inconvenience and complexity of existing injectable
and intravenous therapies and the safety concerns associated with them. The
science behind this compound is compelling. Through our collaboration with
FibroGen we aim to offer a first-in-class, convenient treatment option for
doctors and patients.”

Thomas B. Neff, Chief Executive Officer, FibroGen, said: “FG-4592 has the
potential to offer anaemia patients an oral therapy that provides coordinated
erythropoiesis, that increases natural erythropoietin within the normal
physiological range, and that is effective without intravenous iron
supplementation and without an increased risk for hypertension. We are
especially pleased that AstraZeneca will share our commitment to making China
the first-to-launch country for FG-4592 and join our effort to bring important
innovation in anaemia therapy to CKD and ESRD patients in the US and other
countries. This agreement secures proper development and commercialisation
resources for FG-4592, and ensures US clinical trial efforts are fully funded.”

– ENDS –

NOTES TO EDITORS

About chronic kidney disease and anaemia

Diabetes, high blood pressure, and other conditions can cause significant damage
to the kidneys. If left untreated, those can result in chronic kidney disease
and progress to kidney failure. Such deterioration can lead to patients needing
a kidney transplant or being placed on dialysis to remove excess fluid and
toxins that build up in the body. The progression of CKD also increases the
prevalence of anaemia, a condition associated with having fewer of the red blood
cells that carry oxygen through the body, and/or lower levels of haemoglobin,
the protein that enables red blood cells to carry oxygen. As haemoglobin falls,
the lower oxygen-carrying capacity of an anaemic patients’ blood results in
various symptoms including fatigue, loss of energy, breathlessness, and angina.
Anaemia in CKD patients has been associated with increased hospitalisation
rates, increased mortality, and reduced quality of life.

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CKD is a worldwide critical healthcare problem that affects millions of people
and drives significant healthcare cost.  In the US, prevalence of CKD has
increased dramatically in the past 20 years, from 10% of the adult population
(or approximately 20 million US adults) as stated in the National Health and
Nutrition Evaluation Survey (NHANES) 1988-1994, to 15% (or approximately 30
million adults) in NHANES 2003-2006.  In 2009, total Medicare costs for CKD
patients were $34 billion. China has an estimated 125 million CKD patients, or 5
times the number of CKD patients in the US [Lancet April 2012].

About FG-4592

FG-4592 is an orally administered small molecule inhibitor of hypoxia-inducible
factor (HIF) prolyl hydroxylase activity, in development for the treatment of
anaemia in patients with chronic kidney disease (CKD). HIF is a protein
transcription factor that induces the natural physiological response to
conditions of low oxygen, “turning on” erythropoiesis (the process by which red
blood cells are produced) and other protective pathways. FG-4592 has been shown
to correct anaemia and maintain haemoglobin levels without the need for
supplementation with intravenous iron in CKD patients not yet receiving dialysis
and in end-stage renal disease patients receiving dialysis. An Independent Data
Monitoring Committee has found no signals or trends to date to suggest that
treatment with FG-4592 is associated with increased risk of cardiovascular
events, thrombosis, or increases in blood pressure requiring initiation or
intensification of antihypertensive medications.

Under a licensing agreement between FibroGen, Inc. and Astellas Pharma Inc.,
Astellas is developing FG-4592 for the treatment of anaemia in CKD and ESRD
patients in Europe, Japan, the Commonwealth of Independent States, the Middle
East, and South Africa.

About FibroGen

FibroGen, Inc., is a privately-held biotechnology company focused on the
discovery, development, and commercialization of therapeutic agents for
treatment of fibrosis, anaemia, cancer, and other serious unmet medical needs.
FibroGen’s FG-3019 monoclonal antibody is in early-stage clinical development
for treatment of idiopathic pulmonary fibrosis and other proliferative diseases,
including pancreatic cancer and liver fibrosis, and FG-4592 is a small molecule
inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase currently in
clinical development for the treatment of anaemia. FibroGen is also currently
pursuing the use of proprietary recombinant human type III collagens in
synthetic corneas for treatment of corneal blindness. For more information
please visit: www.fibrogen.com  

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com

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CONTACTS

Media Enquiries

 

Ayesha Bharmal

 

+44 20 7604 8034 (UK/Global)

Esra Erkal-Paler

 

+44 20 7604 8030 (UK/Global)

Vanessa Rhodes

 

+44 20 7604 8037 (UK/Global)

Michele Meixell

 

+1 302 885 2677 (US)

Jacob Lund

 

+46 8 553 260 20 (Sweden)

Investor Enquiries

 

 

Ed Seage

 

+1 302 373 1361

Colleen Proctor

 

+1 302 357 4882

 

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brackets, has been omitted because it is both (i) not material and (ii) would
likely cause competitive harm to the company if publicly disclosed.