[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

Amendment No. 1 To Collaboration Agreement

This Amendment No. 1 (the “First Amendment”) is effective as of January 1, 2013
(the “First Amendment Effective Date”) by and between Astellas Pharma Inc.
(“Astellas”) and FibroGen, Inc. (“FG”). This First Amendment amends the
Collaboration Agreement entered into by and between Astellas and FG on June 1,
2005 (the “Agreement”). Astellas and FG shall be referred to individually herein
as a “Party” and collectively as the “Parties”.

Whereas, under the Agreement, Astellas and FG have agreed to collaborate on the
development and commercialization of certain small molecule prolyl hydroxylase
inhibitors as therapeutics in the Astellas Territory;

Whereas, Section 12.2 of the Agreement provides that FG shall have the worldwide
exclusive right to manufacture Lead Compound, and that Astellas and its
Affiliates and Sublicensees shall not directly or indirectly make, produce or
manufacture any Lead Compound;

Whereas, Section 12.3 of the Agreement provides that FG shall have the exclusive
right and obligation to supply Lead Compound to Astellas and its Affiliates and
Sublicensees for all development and commercial purposes, and that Astellas and
its Affiliates and Sublicensees shall purchase such Lead Compound exclusively
from FG;

Whereas, Section 12.4 of the Agreement provides that, upon Marketing Approval
for any Lead Compound, FG’s obligation to supply Astellas with Lead Compound
shall be limited to, and all payment obligations shall be based on, the supply
of Bulk Product, as set forth in Section 9.2 of the Agreement;

Whereas, Article 9 of the Agreement contains certain transfer pricing provisions
to compensate FG for the manufacture and supply of Lead Compound(s) to Astellas;

Whereas, the Parties hereby agree that the amendments to the Agreement contained
in this First Amendment are not intended to be and shall not be deemed an
Amendment to that certain Anemia License and Collaboration Agreement, by and
between FG and Astellas, dated April 28, 2006 as amended (“EU Agreement”);

Whereas, subject to the terms and conditions of this First Amendment, and
notwithstanding anything to the contrary contained in the Agreement, with
respect solely to the compound designated by FG as FG-4592 and a current Lead
Compound, FG shall not supply to Astellas Lead Compound formulated as bulk drug
product, but shall instead supply Astellas with the active pharmaceutical
ingredient of FG-4592, also known as roxadustat (“FG-4592”) (and, for the
avoidance of doubt, only FG-4592) in the form of drug substance (“API”) solely
for use by Astellas to formulate, fill, and finish into bulk drug product
containing FG-4592, in a formulation and pursuant to the manufacturing method
and process approved by FG (“Astellas Bulk Product”); and

Whereas, subject to the terms and conditions of this First Amendment, FG agrees
that Astellas shall have the right to manufacture Astellas Bulk Product for
non-commercial and commercial purpose (each such term to be used in this First
Amendment as set forth in Article 9 of the Agreement) in the Astellas Territory
(Japan) using API exclusively supplied by FG.

Now, Therefore, for good and valuable consideration, the receipt and sufficiency
of which is hereby acknowledged, the Parties agree as follows:

1)

Unless otherwise defined herein, all capitalized terms and phrases used in this
First Amendment shall have the meaning ascribed to them in the Agreement.

2)

With respect to FG-4592 only, references to the Lead Compound in the Agreement
shall be deemed references to API, including pursuant to Article 12 of the
Agreement and in Section 17.3 and in the exception clause at the end of Section
17.2 of the Agreement, Sections 9.1 and 9.2 and additional articles and
sections, as amended hereby, to the extent applicable to accomplish the Parties’
intent under this First Amendment. In addition, with respect to FG-4592, the
term “Product Specifications”, as defined in Section 1.56 of the Agreement will
apply to API only, provided, however, that FG and Astellas shall agree on any
specifications to any Astellas Bulk Product produced by Astellas in any form or
formulation.

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

3)

Astellas shall have the right to manufacture Astellas Bulk Product in the
Astellas Territory solely from API supplied by FG pursuant to Article 12 of the
Agreement as follows:

 

a)

Section 13.1 of the Agreement is amended to designate the existing paragraph
subsection 13.1.1. and to add the following paragraph governing supply of
FG-4592 as subsection 13.1.2:

13.1.2“With respect to FG-4592, and subject to the terms and conditions of this
Agreement, FG hereby grants to Astellas an exclusive license under the FG
Technology in the Astellas Territory to: (a) import API exclusively supplied by
or on behalf of FG; and (b) manufacture and have manufactured Astellas Bulk
Product from such API, solely for use pursuant to the license granted in Section
13.1.1.”

 

b)

Astellas shall manufacture Astellas Bulk Product (i) solely in the Astellas
Territory for use and sale in the Astellas Territory in accordance with the
terms of the Agreement and (ii) solely using API supplied by or on behalf of FG.

The intent of this Amendment is that the Astellas will subcontract manufacturing
of Astellas Bulk Product to its Affiliate Astellas Pharma Tech Co., Ltd. to
manufacture at its facility in [*]. Astellas may subcontract its manufacture of
Astellas Bulk Product to another Affiliate and/or a third party for
non-commercial and commercial manufacturing pursuant to an agreement
pre-approved in writing by FG (any such third party, excluding Astellas Pharma
Tech Co., Ltd., a “Subcontractor”), provided, [*]. Astellas shall be responsible
for and ensure: (i) the compliance of each Subcontractor with the terms of the
Agreement, (ii) that each Subcontractor undertakes in writing to (a) obligations
of confidentiality and non-use regarding Confidential Information consistent
with the terms of Article 16 of the Agreement; (b) a quality agreement between
Astellas and Subcontractor that conforms with terms of the applicable Drug
Product Agreement; and (c) an agreement that restricts Subcontractor from [*]
after the expiration or termination of the agreement, and (iii) each
Subcontractor agrees in writing to assign all inventions and other intellectual
property made related to any such work in connection with Astellas Bulk Product
to Astellas (and Astellas will in turn assign to FG as provided in the
Agreement). For the avoidance of doubt, FG shall have the right to visit,
conduct technical review and audit any Subcontractor with respect to all aspects
of the manufacturing process and methods, and FG shall have the opportunity to
review any agreements related to the manufacture of the Astellas Bulk Product
between such pre-approved Subcontractor and Astellas prior to execution (other
than financial terms); provided, further, that the technical review and audit
process shall be conducted in accordance with the procedure set forth in Section
10 of this First Amendment.

4)

Astellas hereby expressly agrees that any API supplied by FG under the
Agreement, as amended by this First Amendment shall be used only to manufacture
Astellas Bulk Product, including any of the activities set forth in Exhibit A
under the heading “Permitted Activities” (“Permitted Activities”) and any
administrative related activities thereof. For clarity, Astellas shall not take
any other action with respect to, or make any other use of such API for any
other purpose, including without limitation any of the activities set forth in
Exhibit A under the heading “Prohibited Activities” (“Prohibited Activities”).
FG from time to time has transferred to Astellas API and other materials and
permitted Astellas to conduct manufacturing development activities in
anticipation of the execution of this First Amendment. Astellas represents and
warrants that it has at all times complied with the terms of Material Transfer
Agreement Letter dated January 31, 2013, Material Transfer Agreement Letter
dated March 8, 2013, Material Transfer Agreement dated June 10, 2014 and
Material Transfer Agreement dated June 15, 2018 between FG and Astellas
(collectively, “MTAs”) regarding the materials provided thereunder, including
without limitation performing only the permitted and not conducting any
prohibited activities set forth in the applicable MTAs. The Parties hereby agree
that (i) any use of API except for Permitted Activities under this Amendment
after November 30, 2018 or (ii) any use of the materials provided under the MTAs
by Astellas other than the permitted purposes specified in the applicable MTAs
shall constitute a breach under Section 18.2.1 of the Agreement, and if any such
material breach is not cured pursuant to Section 18.2.1 of the Agreement, FG
shall have the right to terminate the Agreement thereunder. If Astellas wishes
to conduct any other activities with the API, it may do so only upon prior
written approval by FG.

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

5)

The Parties agree that FG has provided all FG Technical Information necessary
for Astellas or Subcontractor to manufacture Astellas Bulk Product from API
according to the process approved by the Parties. In the event that Astellas
wishes to conduct a technology transfer process to another Subcontractor,
Astellas may do so provided that FG can, [*], review and approve in writing, the
technology transfer protocol of Astellas and the Subcontractor prior to the
commencement of technology transfer activity , and review the post-transfer
report to confirm the transfer complied with the technology transfer protocol,
and any deviations are reasonably acceptable to FG, provided that if any
deviations are not reasonably acceptable, FG, Astellas and the applicable
Subcontractor shall work together to agree on a resolution acceptable to all
parties, provided further that FG shall use commercially reasonable efforts to
prevent any delay on Astellas’s technology transfer activities.

6)

The Parties confirm that they have executed a Quality Assurance Agreement
(“QAA”) dated November 17th, 2014, including a Product Technical Agreement
governed thereby (“PTA”) dated November 17th, 2014, to govern the
responsibilities of both Parties with respect to manufacture, storage,
transportation, export/import, testing, specifications and release of API for
non-commercial purposes, as amended by this First Amendment (“API QAA and PTA”).
The Parties confirm that they have executed an API QAA and PTA for commercial
purposes.

7)

FG shall approve, prior to the production of the Validation Batches, (i) the
validation protocol, and (ii) any validation protocol amendments. In addition,
Astellas shall send the validation report thereof to FG for review and comment
prior to its finalization, as well as the final validation report after
finalization. In addition to the foregoing, a separate agreement for Astellas
Bulk Product (“Drug Product Agreement”) shall be negotiated and executed to
govern manufacturing for commercial and non-commercial purposes. The Parties
shall agree upon a Drug Product Agreement for commercial purposes as soon as
reasonably practicable [*] and prior to earlier of (a) [*], and (b) [*]. The
manufacturing methods and specifications, quality standards (i.e. compliance
with Astellas SOPs and applicable laws and regulations), and applicable laws and
regulations for Astellas Bulk Product for commercial purpose will be
incorporated and described in the Drug Product Agreement at the same level of
detail as the CTD Module 1 for the Marketing Approval Application in the
Astellas Territory (Japan) plus any additional detail reasonably requested by
FG. If Astellas proposes to make any change to the manufacturing methods,
specifications, or quality provisions set forth in the Drug Product Agreement or
that materially affect product quality, then Astellas shall notify FG of the
proposed changes, and the Parties shall thereafter discuss and agree as to
whether and what changes may be made pursuant to an amendment to the Drug
Product Agreement, provided that the Parties shall take into consideration
whether such change was requested by Japanese regulatory authorities.

8)

Astellas shall, by itself or through its Subcontractor, maintain all master
batch records, batch records (including executed batch records) and all
supporting documentation, quality control documentation (including deviation
reports), stability reports, annual reviews, regulatory submissions, acceptance
test results and other relevant information for each batch of Astellas Bulk
Product (collectively, “Processing Data”) for [*], or such longer time as
required by the applicable laws and regulations. FG shall have the right to
review such Processing Data upon reasonable request, including without
limitation in preparation of any anticipated inspections (e.g., a pre-approval
inspection), by visiting at FG’s option Astellas’ or its Subcontractor’s
facility and/or requesting a copy of such Processing Data, each Party to bear
its own cost and expense.

9)

Astellas shall be responsible for obtaining and maintaining all necessary plant
inspection standards, plant licenses, permits and approvals to manufacture and
package (including label) Astellas Bulk Product as required under applicable law
and regulations.

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

10)

FG shall have the right, upon reasonable advance notice (which shall include the
scope or purpose during regular business hours), to conduct technical visit and
review of Astellas Bulk Product manufacturing facilities or other facilities
utilized in the performance of related activities for Astellas Bulk Product
(e.g. analytical testing, packaging, labeling, etc.) by Astellas (or its
applicable Subcontractor) to ensure compliance with applicable laws, rules and
regulations, including, without limitation, Japanese regulatory standards and
quality and technical standards set forth in the Drug Product Agreement (the
“Relevant Standards”). Such technical visit and review shall be conducted at
FG’s cost and expense in a manner so as to minimize disruption of Astellas’ or
its Subcontractor’s business operations. If FG finds any deficiencies arising in
the review, FG shall send written notice detailing such deficiencies to
Astellas, the Parties shall meet to discuss, and Astellas shall as soon as
possible (but no later than [*] after receipt of such notice (or [*] for
critical observations), submit a plan to FG outlining measures proposed to be
taken to remedy such deficiencies, and the Parties shall discuss and agree upon
any measures to be taken by Astellas, subject always to the requirements of the
Japanese regulatory authorities and recognizing Astellas’ role and
responsibilities as the marketing authorization holder in Japan.

11)

Astellas shall be responsible for procuring all excipients required for the
manufacture of Astellas Bulk Product from raw material suppliers qualified by
Astellas, and FG will have the right to review a statement and other documents
relied upon for qualification status (including audit reports, to the extent
Astellas obtained approval from such raw material suppliers to disclose them to
FG, which approval Astellas shall use commercially reasonable efforts to obtain,
if requested by FG) of such raw material suppliers and a summary of Astellas’
audit program. All such excipients must comply with all applicable
specifications, standard operating procedures, all applicable laws and
regulations, and any Marketing Approvals in the Astellas Territory for the
Astellas Bulk Product.

12)

Upon execution of this Amendment, Astellas will provide a rolling [*] forecast
of its anticipated API Batch (as defined below) requirements on a [*] basis, as
well as the corresponding Astellas Bulk Product tablet manufacturing plan for
such API Batches. Astellas will provide to FG written updates to such forecast
by the [*] thereafter.

13)

Astellas acknowledges that FG will manufacture and supply API to Astellas [*],
that each API batch equals to approximately [*] (“API Batch(es)”), and any API
Firm Purchase Order (as defined below) shall be for [*].

14)

For any API that Astellas wishes to purchase, Astellas will provide FG with a
binding purchase order specifying (a) the [*], (b) the requested date of
Delivery, and (c) all other relevant information as agreed by FG and Astellas,
as early as possible and in no event less than [*] prior to requested Delivery
date (“API Firm Purchase Order”). FG will manufacture and deliver API Batches as
requested in an API Firm Purchase Order(s). All forecasts and API Firm Purchase
Orders will be prepared in good faith in order to facilitate FG's manufacture
and shipment of API in compliance with the Agreement.

15)

Subject always to the requirements under Sections 13 and 14, Astellas shall
submit API Firm Purchase Orders to FG from time to time, and FG shall supply the
quantity of API Batches requested in each API Firm Purchase Order that complies
with this Agreement and Section 14 of this Amendment, provided that (i) if
Astellas has submitted a forecast for the time periods listed below in (a) – (c)
it shall provide API Firm Purchase Orders that fall within the ranges set forth
therein, and (ii) the [*] ordered in a calendar quarter is within all of the
following ranges:

 

a)

[*] and [*] of the amount forecast for such API for the calendar quarter [*]
from the calendar quarter of the Delivery date;

 

b)

[*] and [*] of the amount forecast for such API for the calendar quarter [*]
from the calendar quarter of the Delivery date;

 

c)

[*] and [*] of the amount forecast for such Bulk Product for the calendar
quarter [*] from the calendar quarter of the Delivery date; provided however,
that

 

d)

if, due to the limitations in Section 13 and in (a) – (c) above, the number of
batches forecasted for any calendar year by Astellas is insufficient to allow
for the ordering of [*] in any calendar quarter, notwithstanding such
limitations, Astellas shall be entitled to order and purchase pursuant to an API
Firm Purchase Order [*] in such calendar year.

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

Within [*] after its receipt of an API Firm Purchase Order complying with the
requirements of this section 15, FG shall acknowledge its receipt of such order
and shall confirm the requested Delivery Date of the Bulk Product. For API
requested in any Purchase Order exceeding the quantity or Delivery Date
parameters set forth above, FG agrees that it shall use reasonable efforts to
fill as much of such excess order as FG can reasonably manufacture and supply in
a timely manner. FG shall include in its response to Astellas such excess amount
and Delivery Date which FG is able to supply.

Astellas and FG shall enter into a commercial supply agreement by [*]. Such
commercial supply agreement shall govern the detailed conditions of supply of
API by FG to Astellas, including the full forecasting and permitted variation
provisions, binding order commitments, etc. contained herein, as well as other
standard commercial supply agreement provisions which shall be consistent with
the terms and conditions herein and in the Agreement in all aspects, and contain
other reasonable and customary provisions, including without limitation
provisions for security of the product (defined as procedures to reasonably
protect against diversion, counterfeit, etc.), full accounting and
reconciliation of API and Astellas Bulk Product.

16)

For API supplied by FG to Astellas for a non-commercial purpose, Astellas shall
compensate FG pursuant to the provisions of Section 9.1 of the Agreement. For
API supplied by FG to Astellas for commercial purposes, including Astellas Bulk
Product manufactured in the validation process (“Validation Batch”), Astellas
shall pay FG on a per batch basis an amount calculated pursuant to the
provisions of Section 9.2 of the Agreement (the “API Batch Transfer Price”), as
defined below. In 2018, FG shall deliver to Astellas [*] batches of API (the
“2018 API Batches”), a portion [*] of which has been delivered to Astellas in
advance of the execution of this First Amendment and the remaining portion [*]
for which Astellas shall deliver to FG a purchase order within [*]. Astellas
shall pay to FG for the 2018 API Batches the API Batch Transfer Price agreed by
the Parties under the letter from FG to Astellas dated June 15, 2018 (“2018 API
Batch Transfer Price”) subject to the adjustment set forth in Section 17 below.
Astellas shall pay for the API supplied by FG for the Validation Batches within
[*] of the date of invoice.

The “API Batch Transfer Price” shall be calculated based on (a) the [*]
calculated based on (i) the [*] to be manufactured by Astellas for the upcoming
Astellas fiscal year derived from the manufacturing plan presented in the
then-current Astellas supply forecast, and (ii) the [*] and (b) the [*] less (c)
the Bulk Product Manufacturing Cost.

“Astellas Yield” shall be defined as the [*] from the manufacture by Astellas
(or its subcontractor) of [*] for the prior calendar year on a [*] basis.

“FG Yield” shall be defined as the average yield per strength from the
manufacture by FG (or its subcontractor) of [*] for the prior calendar year on a
[*] basis.

“Bulk Product Manufacturing Cost” shall mean an amount equal to [*].

17)

The API Batch Transfer Price shall be updated by FG annually based on the
updated inputs provided under the following process:

 

a)

No later than the end of February of each calendar year, FG shall provide to
Astellas:

 

(1)

the [*]for the prior calendar year, with the basis of calculation, and

 

(2)

the [*]for the upcoming Astellas fiscal year, with the basis of calculation,
including the [*] to be manufactured by Astellas for the upcoming Astellas
fiscal year based on the manufacturing plan presented in the then-current
Astellas supply forecast.

 

b)

No later than [*] after updated Listed Price is announced in the notice through
official gazette of Japan (“Kanpo”), Astellas shall provide to FG an updated
Listed Price issued by the Japanese Ministry of Health, Labour and Welfare on a
per strength basis for the upcoming year. If the Listed Price is not updated,
Astellas shall notify FG by March 15 of such calendar year.

 

c)

No later than [*] after the receipt of the notice pursuant to (b) above, FG
shall provide to Astellas the updated API Batch Transfer Price for API Batches
to be delivered during the following Astellas Fiscal Year.

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

 

d)

No later than [*] of the receipt of the updated API Batch Transfer Price from FG
in each calendar year, but in no event no later than March 31 of such calendar
year, Astellas shall review and approve the updated API Batch Transfer Price.

 

e)

The updated API Batch Transfer Price takes effect as of the date upon which
Astellas has amended the price of Astellas Bulk Product to wholesalers
reflecting the updated Listed Price (the “Invoice Price Effective Date”) but in
any event no later than March 15 of any calendar year. Astellas shall inform FG
of the Invoice Price Effective Date within [*] from the date of announcement on
the updated Listed Price.

For the transfer of 2018 API Batches, upon FG and Astellas shall determine an
updated API Batch Transfer Price following the procedures set forth in this
Section, provided that the timeline therefor shall be discussed and agreed
separately, but in all cases it shall be determined within [*] of the date on
which the initial issuance of the Listed Price by the Japanese Ministry of
Health, Labour and Welfare. Following the agreement of the updated API Batch
Transfer Price for the 2018 API Batches based on the actual Listed Price (the
“2018 Updated Price”), FG shall issue to Astellas an invoice or Astellas shall
issue to FG an invoice, as the case may be, and the party receiving such invoice
shall pay for the true-up which shall be defined as (i) difference of the 2018
API Batch Transfer Price and the 2018 Updated Price, (ii) multiplied by the
volume of 2018 API Batch, within [*] of the date of invoice.

18)

Commencing the first year after the issuance of the initial Listed Price, within
[*] from the Invoice Price Effective Date in each calendar year, Astellas shall
provide to FG the “API Year End Inventory”, defined as (i) the [*] and (ii) [*]
(as defined below) with the basis of calculation. Regarding the API Year End
Inventory True-Up which shall be implemented at the [*], Astellas shall provide
to FG the API Year End Inventory as of the end of the last business day of the
month preceding the month during which the Listed Price is issued, and such API
Year End Inventory True-Up shall be provided to FG within [*] of the date on
which the API Batch Transfer Price corresponding to initial Listed Price is
determined. FG shall review and approve the API Year End Inventory True Up
within [*] of receipt thereof. Astellas shall pay to FG, or FG shall pay for the
API Year End Inventory True Up within [*] of the date of invoice, which invoice
FG shall deliver to Astellas, or Astellas shall deliver to FG, upon FG’s
approval of API Year End Inventory True Up.

The API Year End Inventory True Up shall be defined as:

 

i)

the difference between

 

(1)

[*], and

 

(2)

[*]

 

ii)

multiplied by [*]

19)

The parties shall true up the API Batch Transfer Price annually, according to
the following process:

 

a)

Within [*] from the date of the Invoice Price Effective Date in each calendar
year, Astellas shall notify FG (i) the actual weighted average of the tablet
strengths (by percentage) which was manufactured by Astellas for the current
Astellas fiscal year; and (ii) amount of API actually used by Astellas for the
manufacture of the Astellas Bulk Product for the current Astellas fiscal year
(the “Actually Used API”).

 

b)

Within [*] thereafter, FG shall provide to Astellas the amount of true-up of the
API Batch Transfer Price for the Actually Used API (the “Transfer Price True
Up”), with the basis of calculation.

The Transfer Price True Up shall be defined as the difference of i and ii below:

 

i)

[*].

 

ii)

[*].

 

c)

Within [*] thereafter, but no later than April 15 of such calendar year,
Astellas shall review and approve the calculations provided for the Transfer
Price True Up.

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

 

d)

Within [*] thereafter, FG shall issue to Astellas an invoice or Astellas shall
issue to FG an invoice, as the case may be, and the party receiving such invoice
shall pay for the Transfer Price True Up within [*] of the date of invoice.

 

e)

Regarding the Transfer Price True Up which shall be applicable to 2018 API
Batches, FG and Astellas shall implement the true-up following the procedures
set forth in this Section, immediately after [*].

20)

Astellas will be solely responsible for all costs related to the loss,
non-conformity or destruction of API Batch(es) purchased under API Firm Purchase
Order and any materials produced therefrom following Delivery of API pursuant to
Section 12.7 of the Agreement.

21)

Astellas shall bear all costs relating to and associated with any Permitted
Activities, including without limitation transporting, importing, receiving and
testing API and manufacturing, testing and releasing Astellas Bulk Product, as
well as any related support provided by FG upon written request by Astellas,
whether by its employees, consultants or contractors, to the extent related to
the Permitted Activities. If FG is to provide support to Astellas, FG shall
provide the estimated costs to Astellas beforehand, and Astellas shall pay the
actual costs incurred within [*] of receipt of invoice from FG therefor.

22)

FG is and shall be the exclusive owner of all inventions and other intellectual
property made related to the Protected Field, which includes for the avoidance
of doubt, any process manufacturing or other activities undertaken by Astellas
or its Subcontractor under this First Amendment or otherwise relating to the
manufacture of FG-4592, subject to certain Astellas’ rights, pursuant to the
provisions of Sections 14.1 and 14.2 of the Agreement. Neither Astellas nor its
Subcontractor shall use any proprietary drug delivery system technology in
connection with FG-4592 or Astellas Bulk Product without FG’s prior written
consent. Astellas shall grant, and hereby grants, a worldwide, fully paid
non-exclusive license to FG pursuant to the provisions of Section 14.1.

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

23)

The Parties agree that the JDC shall appoint a Joint Manufacturing Subcommittee
(the “JMS”) to oversee the manufacture of the product and to provide for
discussion forum for any supply related issues, which committee shall meet on a
quarterly basis, telephonically or in person, unless otherwise agreed by the
Parties, and as needed to address urgent issues related to manufacturing and
supply. Each Party shall initially appoint three (3) representatives to serve on
the JMS. Each representative appointed to the JMS shall have sufficient
seniority within the applicable Party or its Affiliate to make decisions arising
within the scope of the JMS responsibilities which scope shall be mutually
discussed and agreed by the Parties. Either party may propose agenda items,
which shall be discussed by the Parties at the JMS meetings. 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 JMS shall be
handled under Section 19 of the Agreement, with initial referral to the
Authorized Designees, rather than the JDC, unless otherwise agreed by the
Parties.

24)

In the event of a termination for any reason, and so as to avoid any
interruption of supply, including for reasons of patient safety, and subject to
the requirements of this Section 22, Astellas shall continue to manufacture
Astellas Bulk Product sufficient to meet FG’s requirements in the Astellas
Territory until earlier of (i) [*]. In connection therewith, Astellas and FG
shall mutually agree on manufacturing forecast for Astellas Bulk Product, based
on FG’s reasonable projections and timelines requirements as agreed by the
Parties. Astellas shall notify FG in writing within [*] of the issuance by
Astellas of a notice of termination to FG or receipt by Astellas of a notice of
termination from FG, of its then-current inventory at Astellas and the inventory
expected to be held at Astellas at the effective date of such termination. Any
inventory of Astellas Bulk Product in Astellas’ possession (including that of
any Subcontractor, including any third party labeling or packaging Astellas Bulk
Product), at the effective date of termination and requested by FG, shall be
transferred to FG for its use, including for commercial sale, within the
reasonable timeline as agreed by the Parties, provided that both Parties [*] to
prevent any material disruption in the market. For such Astellas Bulk Product,
and any finished (packaged) product resulting therefrom, FG shall pay to
Astellas [*]. FG may sell, at its own responsibility, any Astellas Bulk Product
in Astellas packaging, provided that FG shall put additional labeling on
Astellas Bulk Product as required under applicable laws and regulations at its
cost. In furtherance thereof, and commencing upon the receipt of a valid notice
of such termination (unless such termination is capable of being cured and the
breaching party is actively attempting to cure), Astellas shall provide all
technical and manufacturing information and documents sufficient and necessary
to enable cGMP bulk product manufacturing by FG, including without limitation, a
technology transfer from Astellas to FG and/or its Affiliates or
subcontractor(s) of Astellas technical information, including but not limited to
methods, specifications, processes, and other information or parameters as FG
and Astellas deem reasonable to continue and complete the manufacture of
Astellas Bulk Product and archival or storage of any finished product resulting
therefrom; and Astellas shall conduct all such transfer to FG or its Affiliate
or Subcontractor in accordance with the timeline agreed by the Parties. FG will
use reasonable efforts to minimize the burden on Astellas to create additional
documentation needed to ensure continued supply of product and efficient
response to regulatory requirements, etc., provided that FG shall bear
Astellas’s reasonable cost necessary to create additional documentation. The
period of transitional manufacture and archival and storage of any finished
product resulting therefrom shall not exceed [*] following the effective date of
the termination. In the event that Astellas utilizes a Subcontractor(s) for
manufacture of Astellas Bulk Product (including any vendor involved in packaging
or labeling), upon FG’s request, Astellas shall use commercially reasonable
effort to cooperate to enable FG to (i) enter into a new commercial
manufacturing and supply agreement with any requested Subcontractor; or (ii)
assign existing agreement(s) between Astellas and such Subcontractor(s) to FG;
in either case except for the financial terms to be negotiated between FG and
such Subcontractor(s).

25)

In addition to any reports required to be delivered to FG under Section 10.1 of
the Agreement, in order that FG may comply with its financial reporting
obligations, Astellas shall, within [*] after the end of each calendar quarter,
provide FG with a manufacturing and inventory report for all API and Astellas
Bulk Product (including, for the avoidance of doubt, finished and/or labeled and
packaged product, and product designated as samples, if any) in the possession
of Astellas or its Subcontractor at the end of each such calendar quarter,
including the status, disposition, and expected use thereof, in the detail and
form reasonably satisfactory to FG and as outlined on Exhibit B.

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

26)

Section 20.6 (Notices) is hereby amended to reflect the Parties’ current notice
information, as follows:

Astellas:

Astellas Pharma Inc.

 

Attn: Vice President, Legal

 

[*]

 

 

 

 

with copy to:

Astellas Pharma Inc.

 

Attn: Vice President, Business Development

 

[*]

 

 

 

 

FG:

FibroGen, Inc.

 

Attn: Chief Executive Officer

 

409 Illinois Street

 

San Francisco, California 94158

 

United States of America

with a copy to:

FibroGen, Inc.

 

Attn: Chief Legal Counsel

 

409 Illinois Street

 

San Francisco, California 94158

 

United States of America

27)

The Agreement, as amended hereby, contains the entire understanding of the
Parties with respect to the subject matter hereof. The Parties acknowledge that
the amendments to the Agreement contained in this First Amendment are and shall
be of no force or effect with respect to the EU Agreement.

28)

Except as otherwise provided herein, the Agreement has not been modified or
amended and remains in full force and effect. All express or implied agreements
and understandings, either oral or written, heretofore made that conflict with
respect to the subject matter herein are expressly superseded in this First
Amendment.

29)

This First Amendment may be executed in counterparts, each of which shall be
deemed an original, and all of which together shall constitute one and the same
instrument. Counterparts may be signed and delivered by facsimile and/or via
portable document format (.pdf), each of which shall be binding when sent.

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

IN WITNESS WHEREOF, the Parties have executed this First Amendment to the
Agreement as of the First Amendment Effective Date.

FibroGen, Inc.

 

Astellas Pharma Inc.

By:

 

 

By:

 

Name:

 

 

Name:

Mitsunori Matsuda

Title:

 

 

Title:

Senior Vice President and President,

 

 

 

 

Pharmaceutical Technology

 

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

 

Exhibit A:

Prohibited Activities

 

1.

[*]

Permitted activities:

 

1.

[*]

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

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Exhibit 10.9(i)

 

EXHIBIT B:

For the Quarterly Manufacturing Reports, the following information should be
included:

 

•

[*]