Document:

fgen-ex1036_605.htm

EXECUTION COPY

 

 [*] = 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 10.36

 

SAMSUNG BIOLOGICS CO., LTD.

PRODUCT SPECIFIC AGREEMENT – CLINICAL PRODUCT DRUG SUBSTANCE

 

WHEREAS, this Clinical Product Specific Agreement (this “PSA”) is entered into as of the date of the last signature below, and made effective October 30, 2020 (the “PSA Effective Date”) by and between FibroGen, Inc., a Delaware corporation having its principal place of business at 409 Illinois Street, San Francisco, California, USA 94158 (“Client”) and Samsung Biologics Co., Ltd., a company with offices at [*] (“SBL”).  Client and SBL are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

WHEREAS, Client and SBL entered into a Master Services Agreement effective October 30, 2020 (the “MSA”) and whereas pursuant to Section 2.1 of the MSA, the Parties wish to enter into this PSA whereby SBL will provide certain Services as detailed herein with respect to the Clinical Product specified below;

WHEREAS, understanding that Product manufactured under this PSA may be used for either clinical or commercial purposes, the rights and obligations of each Party related to ongoing commercial Manufacturing of the same Drug Substance will be specified in a Product Specific Agreement – Commercial Product Drug Substance (the “Commercial PSA”). Similar terms as those agreed upon in this PSA shall be incorporated into the Commercial PSA.

NOW, THEREFORE, the Parties agree as follows:

	
1.
	
Relationship to the MSA.  All capitalized terms not defined in this PSA will have the meanings given to them in the MSA.  This PSA is hereby incorporated by reference into the MSA.

	
2.
	
Definitions

	
 
	
a.
	
“Campaign” shall mean a series of Batches of the Product that are produced in sequence using the same manufacturing equipment (including but not limited to the same bioreactor) followed by validated cleaning of such equipment and purification suite, and for the purposes of counting the number of Product Batches in a Campaign in a given period, the start date of such Campaign shall be the determining factor. A Campaign will be deemed to end upon the completion of such cleaning.

	
 
	
b.
	
 “PSA Term” is defined in Section 9. 

	
 
	
c.
	
[*].

	
 
	
d.
	
“Year” means each one (1) year period that begins on January 1 and ends on December 31.

	
3.
	
General Information.

	
 
	
a.
	
 Product: [*].

	
 
	
b.
	
 Product Specification: The Product Specification will be contained in mutually agreed upon cGMP documentation and/or the QAA.    

	
 
	
c.
	
Cell Line: [*]

	
 
	
d.
	
Manufacturing Facility: [*].

 

Fibrogen - Samsung Product Specific Agreement (Clinical DS)(38831) 2020 11 05 EXECUTION CLEAN FINAL

[*] = 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.
	
Shelf life of the Product for the purposes of Section 5.9.2(a)(iii) of the MSA is [*], which may be updated by Client and notified to SBL at the JSC. 

	
4.
	
Raw Materials. 

	
 
	
a.
	
Client Materials.  Client Materials to be supplied by Client to SBL free of charge by itself or a third party designee.

	
 
	
i.
	
List: See Exhibit A: Client Materials

	
 
	
ii.
	
Timing of provision of Client Materials to SBL (target) : [*]

	
 
	
b.
	
Raw Materials.  The Parties shall finalize the categorization of Raw Materials to be used in performing the Services of this PSA into Critical Raw Materials, Customized or Dedicated Raw Materials, and Other Raw Materials, and shall attach such list to this PSA as Exhibit B. Raw Materials will be procured by SBL [*]. Handling Fees for all Raw Materials included (Critical Raw Materials, Customized or Dedicated Raw Materials, and Other Raw Materials) for the Product shall be [*]. 

	
5.
	
Technology Transfer, Manufacturing, and Supply Services.  SBL shall perform the Services as set forth in this Section 5.

	
 
	
a.
	
Services.  

	
 
	
i.
	
SBL shall provide the Services as set forth in Exhibit D in accordance with this PSA and the MSA.

	
 
	
ii.
	
Fees and invoicing.  

	
 
	
1.
	
[*].

	
 
	
2.
	
[*].

	
 
	
b.
	
Service Fees. [*].  Additional Service Fees and costs may be detailed in an amendment to this PSA pursuant to Section 17.10 of the MSA or in an Implementation Plan and Budget pursuant to Section 6.2(b) of the MSA. 

 

	
 
	
c.
	
Product Purchase Commitment.

	
 
	
i.
	
Notwithstanding anything to the contrary, during [*](each a “Binding Year”), Client shall order from SBL on a [*], and SBL commits to manufacture, the number of Batches of Product set forth in the table below on the terms and conditions set forth herein and in the MSA (the “Product Purchase Commitment”). The Product Purchase Commitment [*].  [*]. For clarity, the timeline below is an estimate only, and may be subject to change upon mutual agreement of the Parties.  

		
	
[*]
	
[*]

	
[*]
	
[*] 

 

	
 
	
ii.
	
Within [*], Client shall issue a binding Purchase Order for [*] for the [*]. 

	
 
	
iii.
	
[*]. 

	
 
	
1.
	
Upon such notification, then the Parties will meet promptly at the JSC and to discuss in good faith potential options for resolution including, without limitation [*].

	
 
	
2.
	
[*]:

 

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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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a.
	
[*]. 

	
 
	
b.
	
[*].  

	
 
	
c.
	
[*].

	
 
	
d.
	
[*].  

	
 
	
e.
	
[*].   

[*].

	
 
	
iv.
	
[*]. 

	
 
	
d.
	
Batch Failure.  Pursuant to Section 5.8.3 of the MSA, the Parties shall be responsible for costs related to Batch Failure as follows:

	
 
	
i.
	
To the extent the Batch Failure is caused by an SBL Assignable Error, SBL shall be responsible for (1) the [*] which amount is to be calculated based on the [*]; (2) SBL’s costs to [*] plus applicable SBL [*] as described in this PSA; (3) [*] as described in this PSA; and (4) [*] which amount is to be calculated based on the [*] as supported by reasonable documentary evidence [*].  Any such cost responsibility shall be issued as a [*].

	
 
	
ii.
	
To the extent the Batch Failure is caused by Client’s breach of its obligations hereunder, [*].  If a Batch Failure is caused by [*].

	
 
	
iii.
	
To the extent no root cause of the Batch Failure is identified, [*]. 

	
6.
	
Regulatory Filings.  Client’s regulatory filings covered by this PSA are clinical trial applications (e.g., USA IND, EU CTA/IMPD, China CTA (which in the case of China, may require additional fees)) commercial marketing applications (e.g., US BLA, EU MAA), as well as other filings as required by local regulatory requirements (e.g., GMP applications, drug master files).  SBL shall use Commercially Reasonable Efforts to support Client’s submissions or applications to any new Regulatory Authority, provided Client has provided SBL with reasonable notice and the Parties agree on an Implementation Plan and Budget, and [*].  Details of the scope of SBL’s Services in regards to Regulatory Approvals shall be detailed in Exhibit D.

	
7.
	
Storage.  Pursuant to Section 5.9 of the MSA, if Client does not direct SBL to prepare Manufactured Clinical Product to be picked up by Client or Client’s designated carrier with a pick-up date within [*], SBL shall store the Clinical Product at the Warehouse for up to [*] depending on the available storage capacity and [*].  [*].  

	
8.
	
Limitation of Liability.  In addition to the limitation of liability in Section 14.1 of the MSA for special, punitive, incidental, indirect or consequential damages, the Parties’ liability under the PSA shall be as set forth in this Section 8.  Except for (i) a Party’s indemnification obligations under Section 13.1(iii) and 13.2(iii) of the MSA; (ii) the Client’s payment obligations under Section 9.3 of the MSA; (iii) [*], or (iv) [*], a Party’s maximum aggregate liability to compensate the other Party for all Damages under this PSA will be [*] in which the cause of such liability lies or exists (whether in contract, tort, strict liability, statute or otherwise), and [*]. [*].    

	
9.
	
Term.  This PSA will commence as of the PSA Effective Date and will continue in full force and effect until all the Services stated under this PSA are completed (“PSA Term”), unless earlier terminated in accordance with the provisions of this PSA and/or Section 15 of the MSA.

 

Fibrogen - Samsung Product Specific Agreement (Clinical DS)(38831) 2020 11 05 EXECUTION CLEAN FINAL

[*] = 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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10.
	
Method Transfer. The Parties agree that, upon request by Client and with appropriate cooperation from Client, SBL will complete the transfer, and validation (if applicable), and to perform all IPC and release testing for Drug Substance, [*], and will use Commercially Reasonable Efforts to complete such activities as soon as reasonably possible, but in any event prior to the commencement of the PPQ batches.

 

 

 

 

 

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Fibrogen - Samsung Product Specific Agreement (Clinical DS)(38831) 2020 11 05 EXECUTION CLEAN FINAL

[*] = 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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The Parties have entered into this PSA as of the date of the last signature below by their respective duly authorized representatives.  

 

	
Samsung Biologics Co., Ltd.
	
 
	
FibroGen, Inc.

	
 
	
 
	
 
	
 
	
 

	
By:
	
/s/ Tae Han Kim
	
 
	
By:
	
/s/ Michael Martinelli 

	
Name:
	
Tae Han Kim
	
 
	
Name:
	
Michael Martinelli

	
Title:   
	
Representative Director & President
	
 
	
Title: 
	
SVP, Manufacturing 

	
Date: 
	
09 November 2020
	
 
	
Date: 
	
05 November 2020

 

 

Fibrogen - Samsung Product Specific Agreement (Clinical DS)(38831) 2020 11 05 EXECUTION CLEAN FINAL

[*] = 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: Client Materials

[*]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fibrogen - Samsung Product Specific Agreement (Clinical DS)(38831) 2020 11 05 EXECUTION CLEAN FINAL

[*] = 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: Categorization of Raw Materials

 

Categorization to be agreed by the Parties.

 

 

Fibrogen - Samsung Product Specific Agreement (Clinical DS)(38831) 2020 11 05 EXECUTION CLEAN FINAL

[*] = 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 C: Service Fees 

[*]

 

 

 

Fibrogen - Samsung Product Specific Agreement (Clinical DS)(38831) 2020 11 05 EXECUTION CLEAN FINAL

[*] = 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 D: Scope of Work

[*]

 

 

 

 

 

 

 

 

Fibrogen - Samsung Product Specific Agreement (Clinical DS)(38831) 2020 11 05 EXECUTION CLEAN FINAL

[*] = 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.fgen-ex1044_204.htm

Exhibit 10.44

 

 

October 22, 2020

 

Mark Eisner, M.D., M.P.H.

[PRIVATE ADDRESS]

 

Dear Mark,

 

FibroGen, Inc. is pleased to offer you the position of Chief Medical Officer reporting to me.  The effective date of your employment ("Effective Date") will be set, as mutually agreed upon in advance with FibroGen, Inc. (“FibroGen”) and confirmed with Human Resources. 

 

This offer of employment is made contingent upon successful completion of FibroGen’s background check or upon completion of all required documentation that will be made available to you on the Effective Date. This includes verification of the information provided online and your employment application. If necessary, you will be contacted to resolve any discrepancies in the verification of information. Your employment hire date will be determined after the completion of the background check process and your signed acceptance of this offer.

 

The terms of this offer of employment are as follows:

 

	
1.
	
Compensation. FibroGen will pay you a starting annual salary of $600,000, payable in semi-monthly installments on our regular paydays in accordance with FibroGen's standard payroll policies. Your salary will begin as of the Effective Date.  The position is classified as exempt and therefore not eligible for overtime pay. The first and last payment by FibroGen to you will be adjusted, if necessary, to reflect a commencement or termination date other than the first or last working day of a pay period.

 

	
2.
	
Signing Bonus.  FibroGen will pay you a sign-on bonus in the amount of $1,500,000 (subject to applicable payroll taxes and withholdings) to be payable, contingent up on your continued employment with the Company, in three installments as follows:

 

	
 
	
a.
	
$500,000 on the first payroll date following the Effective Date of your employment

	
 
	
b.
	
$500,000 on March15, 2021

	
 
	
c.
	
$500,000 on August 2, 2021

 

	
3.
	
Stock Options and Restricted Stock Units.  You will be granted the following equity incentive grant(s) pursuant to the terms and conditions of the Equity Plan effective on the date of acceptance of this letter (the “Equity Plan”), as may be amended or modified from time to time:

	
 
	
•
	
a stock option to purchase 80,000 shares of FibroGen's Common Stock with an exercise price set at the fair market value on the date of grant (“Stock Options”); and 

	
 
	
•
	
a grant of 35,000 restricted stock units relating to shares of FibroGen’s Common Stock (“RSUs”).

The actual number of shares subject to the grant hereunder may be adjusted, if required, for events such as stock splits, stock dividends, etc. pursuant to the Equity Plan.  The Stock Options and RSUs will vest according to the schedule set forth in the Equity Plan.

 

	
4.
	
Bonus Plan. You  will be eligible to participate in FibroGen’s Incentive Compensation Plan (the “Bonus Plan”)  adopted by FibroGen for its employees on such terms as FibroGen's Board of Directors (the "Board") may determine in its discretion. 

 

 

 

 

The target bonus for your level will be 50%.  Under the terms of the Plan, both corporate and individual performance is assessed annually and subject to final approval by the Company’s Board of Directors.  Employees hired during the course of a year will have a pro-rated bonus provided they commence their employment on or before September 30th of a calendar year. To remain eligible, employees must maintain satisfactory performance and be in an active status on the day of payment.  Payments are expected to occur no later than the 15th of March in the year following the performance cycle.

 

	
5.
	
Change in Control and Severance Agreement.  You will be eligible to enter into the form of Company’s Change in Control and Severance Agreement approved by the Board that provides for certain severance benefits upon a termination following a Change in Control (as defined therein) and upon certain other terminations.

 

	
6.
	
Benefits. During the term of your employment, you will be eligible to participate in FibroGen’s benefits program, which may include FibroGen's standard vacation benefits and other employee benefits such as medical, vision and dental health insurance, covering employees and officers. These benefits may be modified or subject to change from time to time. A copy of FibroGen's current benefits summary has been provided to you.

 

	
7.
	
Employment Eligibility. You will also be required to sign the Employment Eligibility Verification (Form I-9).  (You will need to complete and return Section One of Form I-9 along with your signed offer letter). On your first day of employment, please bring the necessary original documents that establish your identity and employment eligibility to work in the United States. Acceptable documents are listed on the reverse side of Form I-9. Such documentation must be provided to us within three (3) business days of your date of hire, or our employment relationship with you may be terminated.

 

	
8.
	
Proprietary Information. You will abide by FibroGen’s strict company policy that prohibits any new employee from using or bringing with them from any prior employer any proprietary information, trade secrets, proprietary materials or processes of such former employers.  Moreover, because FibroGen’s proprietary information is extremely important, this offer of employment is expressly subject to your execution of the enclosed Confidential Information, Secrecy and Invention Agreement for Employees. 

 

	
9.
	
At Will Employment.  You should be aware that your employment with FibroGen is for no specified period and constitutes "at-will" employment.  As a result, both FibroGen and you are free to terminate the employment relationship at any time, for any reason or for no reason, and with or without advance notice. The changing needs of FibroGen could also result in changes to certain aspects of your employment, such as compensation, responsibilities, location, etc. These provisions expressly supersede any previous representations, oral or written. Your at-will employment cannot be modified or amended except by written agreement signed by both you and the Chief Executive Officer of FibroGen.

 

	
10.
	
Arbitration.  Any dispute or claim, including all contract, tort, discrimination, and statutory claims, arising under or relating to your employment or termination of your employment with FibroGen (“Arbitrable Claim(s)”) shall be resolved by arbitration.  “Arbitrable Claims” shall not include: (1) claims under applicable workers’ compensation law, (2) unemployment insurance claims, and (3) any disputes or claims relating to or arising out of the misuse or misappropriation of trade secrets.  You and FibroGen hereby waive any rights each may have to a jury trial in regard to Arbitrable Claims.  Arbitration for Arbitrable Claims will be conducted by the American Arbitration Association (“AAA”) in San Francisco (or other mutually agreed upon city) under the Employment Arbitration Rules and Mediation Procedures (“AAA Rules”). The AAA Rules are available at https://www.adr.org/sites/default/files/EmploymentRules_Web_0.pdf, or can be obtained by contacting the FibroGen Human Resources department or by calling AAA at 800-778-7879.  FibroGen will pay the fees and costs of the arbitrator.  The arbitrator shall have the same authority as a court to award equitable relief, damages, costs, and fees (excluding the costs and fees for the arbitrator) as provided by law for the particular claims asserted.  The arbitrator shall also have exclusive authority to rule on his or her own jurisdiction, 

 

 

		
including any objections with respect to the existence, scope, enforceability or validity of the arbitration agreement. Such arbitration shall be final and binding on the parties and shall be the exclusive remedy for Arbitrable Claims.

 

Unless otherwise notified by FibroGen, this offer of employment is effective for five business days from the date of this letter.  However, if you have any questions regarding the above provisions including the arbitration provision, please do not hesitate to contact us. 

 

In the event of conflict between the terms contained in this offer letter and any other document, the terms of this offer letter (including any amendment to this letter) shall control.  FibroGen reserves the right to amend the terms contained in this offer letter from time to time.  

 

 

We look forward to your joining our team at FibroGen. 

 

Sincerely,

 

 

	
	
/s/ Enrique Conterno

	
Enrique Conterno

	
Chief Executive Officer

 

 

				
	
ACCEPTED AND AGREED TO this

	
 

	
24
	
Day of
	
October
	
, 2020

 

 

	
	
/s/ Mark Eisner

	
Mark Eisner, M.D., M.P.H.

	
 

	
December 1, 2020

	
Intended Start Date

	
 

 

Enclosures:Benefits Overview

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