Document:

agle-ex1012_839.htm

EXHIBIT 10.12

 

	
 
	
[*]
	
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 Exchange Act of 1934, as amended.

 

Amended and Restated Patent License Agreement

Agreement No. PM1401501 

This Amended and Restated Patent License Agreement (“Patent License Agreement”) is between the Licensor and the Licensee identified below (collectively, “Parties”, or singly, “Party”).

Background

Licensor owns or controls Patent Rights. Licensee desires to secure the right and license to use, develop, manufacture, market, and commercialize the Patent Rights. Licensor has determined that such use, development, and commercialization of the Patent Rights is in the public’s best interest and is consistent with Licensor’s educational and research missions and goals. Licensor desires to have the Patent Rights developed and used for the benefit of Licensee, the inventors, Licensor, and the public.

Licensor has previously entered into two separate license agreements with subsidiaries of Aeglea BioTherapeutics, Inc. (“Aeglea”). These license agreements are between Licensor and AECase, LLC (PM1401501), and AEMase, LLC (PM140161), respectively, both effective December 24, 2013 (the “Prior Agreements”). Licensor and Aeglea wish to amend certain terms of the Prior Agreements and to combine the two Prior Agreements into this single Amended and Restated Patent License Agreement. This Amended and Restated Patent License Agreement will amend, restate, and supersede the Prior Agreements in all respects.

NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the Parties hereby agree as follows:

The terms and conditions of this Patent License Agreement attached hereto as Exhibit A are incorporated herein by reference in their entirety (the “Terms and Conditions”). In the event of a conflict between provisions of this Patent License Agreement and the Terms and Conditions, the provisions in this Patent License Agreement shall govern. Unless defined in this Patent License Agreement, capitalized terms used in this Patent License Agreement shall have the meanings given to them in the Terms and Conditions.

The section numbers used in the left hand column in the table below correspond to the section numbers in the Terms and Conditions.

				
	
1.
	
Definitions
	
	
 
	
Effective Date
	
Date of last signature below

	
 
	
Licensor
	
The University of Texas at Austin, on behalf of the Board of Regents of the University of Texas System, an agency of the State of Texas, whose address is 3925 W. Braker Lane, Suite 1.9A (R3500), Austin, Texas 78759.

 

 

				
	
 
	
Licensee
	
Aeglea BioTherapeutics, Inc.

	
 
	
Contract Year and Contract Quarters
	
Contract Year is 12-month period ending on December 31 and Contract Quarters are 3-month periods ending on March 31, June 30, Sept. 30, Dec. 31

	
 
	
Territory
	
World-wide

	
 
	
Field
	
All fields

 

							
	
 
	
Patent Rights
	
	
 
	
App. No./
Date of Filing
	
Title
	
Inventor(s)
	
Jointly Owned? (Y/N; if Y, with whom?)
	
Prosecution Counsel

	
 
	
US61/871,727 filed 8/29/2013
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
US61/948,106 filed 03/05/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337  GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
US14/472,779 filed 08/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
South Korea 10-2016-7008 299 filed 08/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
PCT/US2014/0 53374 filed 08/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO) 
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
JP filed 08/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
Israel 244263 I filed 08/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
Europe 14839001.6 filed 08/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
China 201480054224.9 filed 08/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
Canada 2,922,557 filed 08/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
Australia 2014312168 filed 08/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents (6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
 
	
US61/871,768 filed 08/29/2013
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (614 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 2Agreement No. PM1401501

US 4915892v.1

 

							
	
 
	
Patent Rights
	
	
 
	
App. No./
Date of Filing
	
Title
	
Inventor(s)
	
Jointly Owned? (Y/N; if Y, with whom?)
	
Prosecution Counsel

	
 
	
US14/472,750 filed 08/29/2013
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
 
	
South Korea 10-2016-7007-045 filed 08/29/2014
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
 
	
PCT/U52014/ 053359 filed 08/29/2014
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
 
	
JP filed 08/29/2014
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
 
	
Israel 244261 filed 08/29/2014
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
 
	
Europe 14841106.9 filed 08/29/2014
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
 
	
China 20140050681.0 filed 08.29.2014
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
 
	
Canada 2,922,550 filed 08/29/2014
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
 
	
Australia 2014312159 filed 08/29/2014
	
Engineered Human Methionine Gamma Lyase Enzymes and Pharmacological Preparations Thereof (6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
 
	
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USPTO Entity Status as of Effective Date
	
Check one box:

Small☐

Large☐

 

*Confidential Treatment Requested.

 

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 3Agreement No. PM1401501

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2.4
	
Diligence Milestones
	
	
 
	
Diligence Milestones and deadlines
(see Section 20.1)
	
Diligence Milestones
	
Deadlines

	
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*Confidential Treatment Requested.

 
 

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 4Agreement No. PM1401501

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3.
	
Compensation
	
	
3.1(a)
	
Patent expenses due upon Effective Date
	
Amount
	
Based on invoices received as of:

	
 
	
 
	
[*]
	
[*]

 

					
	
3.1(b)
	
Milestone fees
	
 
	
 
	
	
 
	
 
	
Milestone Events
	
Milestone Fees
	
	
 
	
 
	
[*]
	
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7.Obtain Regulatory Approval in any country [*]
	
$5,000,000

	
8.Obtain Regulatory Approval in any country [*]
	
$5,000,000

	
9.Obtain Regulatory Approval for an additional indication in any country [*]
	
$500,000

	
10.Obtain Regulatory Approval for an additional indication in any country [*]
	
$500,000

*Confidential Treatment Requested.

 
 

			
	
3.1(c)
	
Scheduled license fee payments
	
[*]

	
3.1(d)
	
Sublicense Fees
	
 25% of Non-Royalty Sublicensing Consideration from a Sublicense Agreement fully signed before [*]

20% of Non-Royalty Sublicensing Consideration from a Sublicense Agreement fully signed on or after [*] and before [*]

15% of Non-Royalty Sublicensing Consideration from a Sublicense Agreement fully signed on or after [*] and before [*]

6.5% of Non-Royalty Sublicensing Consideration Agreement signed on or after [*]

	
3.1(e)
	
Assignment Fee
	
[*]

	
3.2
	
Running royalty rate (applies to Net Product Sales by Licensee, Affiliates and Sublicensees)
	
[*]

 

				
	
18.
	
Contact Information
	

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 5Agreement No. PM1401501

US 4915892v.1

 

	
 
	
Licensee Contacts
	
Licensor Contacts

	
Contact for Notice:

Attn: David G. Lowe

Aeglea BioTherapeutics, Inc.

901 S. MoPac Expressway

Barton Oaks Plaza One

Suite 250

Austin, TX 78746

Fax: (512) 872-5121

Phone: (512) 942-2935

E-mail: David@aegleabio.com

 

Accounting contact:

Attn: Charles York

Aeglea BioTherapeutics, Inc.

901 S. MoPac Expressway

Barton Oaks Plaza One

Suite 250

Austin, TX 78746

Fax: (512) 872-5121

Phone: (512) 942-2935

E-mail: cyork@aegleabio.com

 

Patent prosecution contact:

Attn: Head of Business and

Corporate Development

Aeglea BioTherapeutics, Inc.

901 S. MoPac Expressway

Barton Oaks Plaza One

Suite 250

Austin, TX 78746

Fax: (512) 872-5121

Phone: (512) 942-2935

E-mail:David@aegleabio.com

contracts@aegleabio.com

 

With a copy to:

Attn: Erin Thomson

Vinson & Elkins LLP

2801 Via Fortuna

Suite 100

Austin, TX 78746

Phone: (512) 542-8762

E-mail: ethomson@velaw.com

 
	
Contact for Notice:

Attn: Contract Manager

3925 W. Braker Lane, Suite 1.9A (R3500)

Austin, TX 78759

Fax: 512 475-6894

Phone: 512 471-2995

E-mail: licensing@otc.utexas.edu

 

Payment and reporting contact:

Checks payable to “The University of Texas at Austin”

Attn: Accounting

3925 W. Braker Lane, Suite 1.9A (R3500)

Austin, TX 78759

Fax: 512 475-6894

Phone: 512 471-2995

E-mail: accounting@otc.utexas.edu

 

Patent prosecution contact:

Attn: Patents

3925 W. Braker Lane, Suite 1.9A (R3500)

Austin, TX 78759

Fax: 512 475-6894

Phone: 512 471-2995

E-mail: patents@otc.utexas.edu

 

 

	
	
For Licensor Administrative Purposes Only

	
Changes to Standard Form Terms and Conditions

Yes

 

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

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20.Special Provision. The Parties hereby agree to the following special provisions set forth in this Section 20 with respect to this Patent License Agreement.

20.1Diligence Milestones.

20.1.1Upon written request from Licensee to Licensor given prior to the scheduled deadline date to achieve a particular Diligence Milestone set forth in Section 2.4, Licensee may request a [*] extension of said Diligence Milestone deadline date; and said request shall be accompanied by evidence that demonstrates to Licensor’s reasonable satisfaction that Licensee (and/or its Affiliates and Sublicensees) have been devoting continued diligent efforts to achieve said Diligence Milestone; and Licensor shall grant the requested extension if Licensor approves the evidence and efforts, which approval will not be withheld unreasonably.

*Confidential Treatment Requested.

 

20.1.2If a first extension has been granted pursuant to Section 201.1 for a particular Diligence Milestone deadline, Licensee may request a [*] extension for the same Diligence Milestone deadline, which request shall be made in accordance with the provisions set forth in Section 20.1.1; and if Licensor grants said request, Licensee shall pay [*] to Licensor as consideration for this second extension, payable within thirty (30) days after Licensee receives written notice that Licensor is willing to grant the extension, which extension will not be effective if said consideration is not paid by said due date. Any failure to so pay said consideration shall not entitle Licensee to make a later delayed payment during any default cure period that is otherwise specified in this Agreement for curing other defaults.

20.2Prior to the assignment of this Patent License Agreement to a third party, “Non-Royalty Sublicensing Consideration” shall be as follows:

[*]

After the assignment of this Patent License Agreement to a third party, “Non-Royalty Sublicensing Consideration” shall be defined as follows:

[*]

20.3If the Parties mutually determine that the rights granted by this Patent License Agreement are essential to the Licensee’s use of any University Invention arising under Sponsored Research Agreement UTA13-001113, then such University Invention shall be included in this Patent License Agreement, upon Licensee’s payment to Licensor of a fee of [*].

20.4This Patent License Agreement replaces and supersedes the Prior Agreements in all respects.

21.No Other Promises and Agreements; Representation by Counsel. Each Party expressly warrants and represents and does hereby state and represent that no promise or agreement which is not herein expressed has been made to such Party in executing this Patent License Agreement except those explicitly set forth herein and in the Terms and Conditions, and that such Party is not relying upon any statement or representation of the other Party or its representatives. Each Party is relying on it’s own judgment and has had the opportunity to be represented by legal counsel. Each Party hereby warrants and represents that it understands and 

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

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agrees to all terms and conditions set forth in this Patent License Agreement and said Terms and Conditions.

22.Deadline for Execution by Licensee.  If this Patent License Agreement is executed first by the Licensor and is not executed by the Licensee and received by the Licensor at the address and in the manner set forth in Section 18 of the Terms and Conditions within thirty (30) days of the date of signature set forth under the Licensor’s signature below, then this Patent License Agreement shall be null and void and of no further effect.

IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Patent License Agreement.

		
	
LICENSOR: THE UNIVERSITY OF TEXAS AT AUSTIN

ON BEHALF OF TH BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM

 

 

 

By:  /s/ Daniel W. Sharp, J.D.
Daniel W. Sharp, J.D.

Associate Vice President for Research and Director, Office of Technology Commercialization

 

Date 1/30/17
	
LICENSEE: Aeglea BioTherapeutics, Inc.

 

 

 

 

 

 

 

By /s/ David G. Lowe
David G. Lowe

President and Chief Executive Officer

 

 

 

Date 31 January 2017

 

 

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 8Agreement No. PM1401501

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Exhibit A
Terms and Conditions of Patent License

These Terms and Conditions of Patent License (“Terms and Conditions”) are incorporated by reference into the Patent License Agreement to which they are attached. All Section references in these Terms and Conditions shall be references to provisions in these Terms and Conditions unless explicitly stated otherwise.

	
1.
	
Definitions

“Affiliate” of a Party means any person, corporation or other business entity which, directly or indirectly through one or more intermediaries, actually controls, is actually controlled by, or is under common control with that Party. As used in this paragraph, “control” means to possess, directly or indirectly, the power to affirmatively direct the management and policies of such person, corporation or other business entity, whether through ownership of at least fifty percent (50%) of the voting securities or by contract relating to voting rights or corporate governance.

“Agreement” means collectively (i) these Terms and Conditions, and (ii) the Patent License Agreement.

“BLA” means Biological License Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, as well as any equivalent foreign application, registration or certification in the relevant country, such as a Marketing Approval Application in Europe, in each case with respect to a Licensed Product.

“Change of Control” with respect to any Party means the occurrence of any of the following events: (i) any “person” (as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended) is or becomes the “beneficial owner” (as defined in Rule 13d-3 under said Act) of securities representing fifty percent (50%) or more of the total voting power represented by such Party’s then -outstanding voting securities; or (ii) the consummation of (A) a merger or consolidation of such Party with any other corporation, other than a merger or consolidation which would result in the voting securities of such Party outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or the entity that controls such surviving entity) at least fifty percent (50%) of the total voting power represented by the voting securities of such Party, such surviving entity or the entity that controls such Party or such surviving entity outstanding immediately after such merger or consolidation, or (iii) the sale or disposition by such Party, to a third party which is not an Affiliate of such Party, of all or substantially all such Party’s assets.

“Commercially Reasonable Efforts” means the expenditure of those efforts and resources used consistent with the usual practice of similarly situated companies in pursuing development or commercialization of its other similar pharmaceutical products with similar market potential and at a similar stage in development.

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 1Agreement No. PM1401501

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“Contract Quarter” means the three-month periods indicated as the Contract Quarter in Section 1 of the Patent License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.

“Contract Year” means the 12-month periods indicated as the Contract Year in Section 1 of the Patent License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.

“Covered” means that with respect to a Patent Right, but for the license granted under this Agreement, the use, manufacture, sale, offer for sale, development, commercialization or importation of the subject matter in question by an unlicensed entity would infringe a Valid Claim of a Patent Right.

“Cumulative Received Capital” means the total funding received by Licensee and its Affiliates after the Equity Financing which funding may be received in connection with any type of transaction, including, without limitation, grants, financings, licensing, research and development, and strategic collaborations.

“Effective Date” means the date indicated as the Effective Date in Section 1 of the Patent License Agreement.

“Enzyme” means [*]

*Confidential Treatment Requested.

 

“Equity Financing” means a transaction or series of related transactions in which License and/or its Affiliates receive at least [*] in in cumulative proceeds from the sale of equity.

“Fair Market Value” means the cash consideration an unaffiliated, unrelated buyer would pay in an arm’s length sale of a substantially identical item sold in the same quantity, under the same terms, and at the same time and place.

“Field” means the field indicated as the Field identified in Section 1 of the Patent License Agreement.

“Government” means any agency, department, unit, or other instrumentality of the United States of America, or any foreign country, or any province, state, county, city or other political subdivision (including any supra-national agency such as in the European Union).

“Gross Consideration” means all cash and non-cash consideration (e.g., securities).

“IND” means an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or comparable filing in a foreign jurisdiction, in each case with respect to a Licensed Product.

“Licensed Process” means a method or process whose practice or use is Covered by a Valid Claim.

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

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“Licensed Product” means any product or component (i) whose manufacture, use, sale, offer for sale or import is Covered by any Valid Claim, or (ii) which is made using a Licensed Process.

“Licensee” means the Party identified as the Licensee in Section 1 of the Patent License Agreement.

“Licensor” means the Party identified as the Licensor in Section 1 of the Patent License Agreement.

“Milestone Fees” means all fees identified as Milestone Fees in Section 3.1(b) of the Patent License Agreement.

“Net Product Sales” means [*]

*Confidential Treatment Requested.

 

“Patent License Agreement” means the particular Patent License Agreement to which these Terms and Conditions are attached and incorporated into by reference.

“Patent Rights” means the Licensor’s rights in (a) the patents and patent applications listed in Section 1 of the Patent License Agreement; (b) all non-provisional patent applications that claim priority to any provisional application listed in Section 1 of the Patent License Agreement; and (c) all divisionals, continuations, and such claims of continuations-in-part as are entitled to claim priority to the aforesaid patents and/or patent applications, and all reissues, reexaminations, extensions of, and foreign counterparts; and (d) any patents that issue with respect to the aforesaid patent applications. From time to time during the term of the Agreement, upon written agreement by both Parties, Licensee and Licensor shall update the list of all patent applications and patents within the Patent Rights.

“Phase II” means a means a human clinical trial of a Licensed Product, including possibly pharmacokinetic studies, the principal purpose of which is to make a preliminary determination that such Product is safe in a patient population for its intended use and to obtain sufficient information about such Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR § 312.21(b). Said trial may be conducted in any country.

“Phase III” means a human clinical trial of a Licensed Product, which trial is designed to: (a) establish that a Licensed Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; (c) support regulatory approval of such Licensed Product; and (d) be generally consistent with 21 CFR § 312.21(c). Said trial may be conducted in any country.

“Prosecution Counsel” means the law firm or attorney who is handling the prosecution of the Patent Rights. Prosecution Counsel as of the Effective Date is identified in Section 1 of the Patent License Agreement.

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“Quarterly Payment Deadline” means the day that is ninety (90) days after the last day of any particular Contract Quarter.

“Regulatory Approval” means, with respect to any country, any and all approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations, or authorizations of any Regulatory Authority necessary for the manufacture, use, storage, import, transport, marketing, and sale (including packaging and labeling) of a product for human use in a country, including approvals of BLAs and NDAs in the United States (and any foreign counterparts or equivalents).

“Regulatory Authority” means any federal, national, multinational, regional, state, provincial or local regulatory agency, department, bureau, commission, council or other governmental entity having jurisdiction over the manufacture, use, storage, import, transport, marketing, and sale (including packaging and labeling)of a Licensed Product in the Territory.

“Sublicense Agreement” means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any license rights of Licensee under the Agreement.

“Sublicense Fee” means the fee specified in Section 3.1(d) of the Patent License Agreement.

“Sublicensee” means any entity to whom an express sublicense has been granted under the Patent Rights.

“Territory” means the territory so indicated as the Territory in Section 1 of the Patent License Agreement.

“Valid Claim” means a claim of (i) an issued and unexpired patent included within the Patent Rights unless the claim has been held unenforceable or invalid by the final, un-reversed, and un-appealable decision of a court or other government body of competent jurisdiction, has been irretrievably abandoned or disclaimed, or has otherwise been finally admitted or determined to be invalid, un-patentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise, or (ii) a pending patent application within the Patent Rights to the extent the claim continues to be prosecuted in good faith provided that if a particular claim has not issued within five (5) years of its initial non-provisional, national-stage filing, it shall not be considered a Valid Claim for purposes of this Agreement unless and until such claim is included in an issued patent and qualifies under subsection (i) of this definition.

	
2.
	
License Grant and Commercialization

	
 
	
2.1
	
Grant

	
 
	
(a)
	
Licensor grants to Licensee a royalty-bearing exclusive license (with the right to sublicense as set forth in Section 2.3) under Patent Rights for the Field and in the Territory to make, have made, distribute, have distributed, 

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

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use, offer for sale, sell, lease, loan, export and/or import Licensed Products.

	
 
	
(b)
	
This grant is subject to any rights of, or obligations to, the Government as set forth in Section 11.2 (Government Rights). Subject to Licensor’s confidentiality obligations under Article 8, Licensor retains the right to practice the Patent Rights for its non-commercial teaching, research, education, and other educationally-related purposes, including the right to (i) publish the scientific findings from such research and (ii) grant third party not-for-profit institutions rights under the Patent Rights solely for non-commercial teaching, research, education, and other educationally-related purposes. In the event Licensor’s Office of Technology Commercialization (“OTC”) becomes aware of any proposed publication, including without limitation by George Georgiou, any researcher working with George Georgiou, or otherwise, that the OTC understands is likely to include the Licensed Products, then OTC agrees to use reasonable efforts  to submit said publication for review by Licensee in advance of publication and to give due consideration to any responsive comments by Licensee. Said draft publication shall be treated as Licensor’s Confidential Information pursuant to Section 8 hereof.

	
 
	
(c)
	
Licensor reserves all rights not expressly granted in the Agreement and disclaims the grant of any implied rights to Licensee.

	
 
	
2.2
	
Affiliates

Licensee may extend the license granted herein to any Affiliate provided that the Affiliate agrees in writing to be bound by the Agreement to the same extent as Licensee. Licensee agrees to deliver such written agreement to Licensor within thirty (30) calendar days following execution. No additional consideration above the consideration defined in this Patent License Agreement shall be due to Licensor in connection with such extension.

	
 
	
2.3
	
Sublicensing

Licensee and its Affiliates have the right to grant Sublicense Agreements under the Patent Rights. Each such Sublicense Agreement must be consistent with the terms of the Agreement, subject to the following:

	
 
	
(a)
	
Each Sublicensee shall be a party to a Sublicense Agreement that is consistent with, no less protective of Licensor’s rights than, and does not conflict with, the terms of this Agreement, and shall include terms and conditions reasonably sufficient to enable Licensee to comply with the terms of this Agreement, including Sublicensor’s right to terminate such Sublicense Agreement if Sublicensee challenges the validity of any Patent Rights in any legal proceeding. Each Sublicense Agreement shall be granted for material consideration. In the event of termination of the 

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Agreement, continued sublicense rights shall be governed by Section 7.5(a) (Effect of Termination). Sublicensees shall have the unlimited right to grant further sublicenses under any sublicense granted by the Licensee or its Affiliates pursuant to this Agreement, provided that (i) a sublicensee of such Sublicensee shall not have the right to grant further sublicenses without the prior written consent of Licensor, which consent shall not be unreasonably withheld or delayed, (ii) any sub-sublicense complies with the terms of this section, and (iii) such sub-sublicense is granted only to the extent it is necessary for commercialization of Licensed Products.

	
 
	
(b)
	
Licensor shall be given a true, complete, and correct copy of each Sublicense Agreement granted by Licensee or an Affiliate, and any modification or termination thereof, within thirty (30) days following the applicable execution of the respective Sublicense Agreement or any amendment to such Sublicense Agreement, and notwithstanding anything to the contrary herein, such Sublicense Agreement shall be deemed Licensee’s Confidential Information. If the Sublicense Agreement is not in English, Licensee shall provide Licensor an accurate English translation of the sublicense. Licensee may redact portions of the Sublicense Agreement which constitute sensitive confidential information, as long as such information is not necessary to calculate or verify amounts owed to Licensor under this Patent License Agreement. Licensee will use good faith efforts to obtain the right to disclose to Licensor copies of any sub-sublicense agreements in a manner consistent with the provisions of this Section 2.3(b).

	
 
	
(c)
	
Notwithstanding any such Sublicense Agreement, Licensee will remain primarily liable to Licensor for all of the Licensee’s duties and obligations contained in the Agreement, including without limitation the payment of running royalties due under Section 3.2.

	
 
	
2.4
	
Diligent Commercialization

Licensee by itself, or through its Affiliates and Sublicensees, will use Commercially Reasonable Efforts to research, develop and commercialize at least one Licensed Product in the Field in the Territory. Without limiting the foregoing, Licensee will fulfill the Diligence Milestones specified in Section 2.4 of the Patent License Agreement by the deadlines indicated therein and (c) use diligent and Commercially Reasonable Efforts to perform and complete the plans described in the annual report submitted pursuant to Section 4.2 (Annual Written Progress Report). Licensor hereby agrees that the efforts of Sublicensees, Affiliates, and any third party contractors shall be deemed the acts of Licensee for purposes of satisfying this Section 2.4, and for the purposes of fees due under Section 3.1(b) of the Patent License Agreement.

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3.
	
Compensation

In consideration of rights granted to Licensee, Licensee will pay Licensor the following fees and royalties. All fees and royalties are not refundable and are not creditable against other fees and royalties. Each payment will reference the Patent License Agreement number and will be sent to Licensor’s payment and accounting contact in Section 18 (Notices) of the Patent License Agreement.

	
 
	
3.1
	
Non-Royalty Payments due from Licensee

	
 
	
(a)
	
Patent Expenses. Licensee will reimburse Licensor for the past patent expenses stated in Section 3.1(a) of the Patent License Agreement within thirty (30) days after the Effective Date. The stated amount is the current estimate for past patent expenses based on invoices received by the Licensor through the stated date. Licensee’s obligations to pay all past and future patent expenses pursuant to Section 6 (Patent Expenses and Prosecution) will not be limited by such amount.

Milestone Fees. Licensee will pay Milestone Fees indicated in Section 3.1(b) of the Patent License Agreement by the Quarterly Payment Deadline for the Contract Quarter in which the Milestone Events set forth in Section 3.1(b) of the Patent License Agreement are achieved. Notwithstanding anything to the contrary, each Milestone Fee is payable only once under this Agreement, with respect to the initial accomplishment thereof, regardless of the number of Licensed Products (or indications therefor) or the number of times such Milestone Event may be achieved. [*]

*Confidential Treatment Requested.

 

	
 
	
(c)
	
Scheduled License Fees. Licensee will pay license fees in the amounts set forth in Sections 3.1(c) of the Patent License Agreement. Licensor will invoice Licensee for such fees in accordance with the stated schedule (i.e., thirty (30) days prior to the due date). Such invoices will be due and payable within thirty (30) days from the date of invoice.

	
 
	
(d)
	
Sublicense Fees. Licensee will pay Sublicense Fees indicated in Section 3.1(d) of the Patent License Agreement on or before the Quarterly Payment Deadline for the Contract Quarter.

	
 
	
(e)
	
Assignment Fee. In the event Licensee assigns this Patent License Agreement to a third party that is not an Affiliate of Licensee, or if Licensee assigns this Patent License Agreement in connection with a Change of Control, Licensee will pay the Assignment Fee forth in Section 3.1(e) of this Agreement within fifteen (15) days of the effective date of such assignment. Assignment Fee shall not be due for an assignment of this Patent License Agreement to an Affiliate of Licensee that is not made in connection with a Change of Control; provided, however, that if such Affiliate ceases to be an Affiliate of Licensee, then an Assignment Fee 

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shall become due and payable to Licensor within fifteen (15) days after such Affiliate ceases to be an Affiliate of Licensee. Assignments are further governed by Section 15 below.

	
 
	
3.2
	
Royalties

Licensee will pay a running royalty at the rate set forth in Section 3.2 of the Patent License Agreement [*], payable on or before the Quarterly Payment Deadline for such Contract Quarter, subject to the following:

*Confidential Treatment Requested.

 

	
 
	
(b)
	
No more than one royalty shall be paid to Licensor hereunder with respect to the sale of any one unit of Licensed Product, whether or not more than one patent or Valid Claim is applicable to the Licensed Product, or the development, manufacture, or performance thereof.

	
 
	
(c)
	
If Licensee, an Affiliate, or a Sublicensee reasonably determines that it is necessary or advisable to obtain a license to any patent(s) or patent application(s) owned, licensed, or controlled by a third party in any country of the Territory, then Licensee shall be entitled to deduct [*] of the consideration paid to any such third party for any such rights in a particular country (such consideration, “Third Party Royalties”) from any payments due Licensor under Section 3.2(a) of this Agreement for Net Product Sales in that particular country, provided that such amounts payable shall not be reduced, with respect to any Contract Quarter below [*] of the amounts otherwise due Licensor with respect to such Contract Quarter for said Net Product Sales without such offset (with any amount of any such consideration not used to reduce payments due Licensor hereunder as a result of such limit remaining available for deduction from amounts due Licensor in future Contract Quarter for Net Product Sales in that particular country, subject to such [*] limit in each Contract Quarter) Licensee, Affiliate, or Sublicensee reasonably determines that it is necessary or advisable to obtain a license to any patent(s) or patent application(s) owned, licensed, or controlled by a Third Party

	
 
	
(d)
	
Should a compulsory license be granted, or be the subject of a possible grant, to a third party under the applicable laws, rules, regulations, guidelines, or other directives of any Government in the Territory under the Patent Rights, the Party receiving notice thereof or otherwise becoming aware thereof shall promptly notify the other Party thereof, including any material information concerning such compulsory license, and the total amount payable under Section 3.2(a) with respect to sales of Licensed Products in such country will be adjusted to match any lower amount such third party may be allowed to pay with respect to the sales of such Licensed Products in such country, with such lower amount subject to further adjustments pursuant to Sections 3.2(c) above.

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(e)
	
Subject to any earlier termination of this Agreement, amounts due under Section 3.2(a) shall only be payable on a country-by-country and Licensed Product-by-Licensed Product basis for Licensed Products that are made or sold in a particular country prior to the first date on which there are no Valid Claims of any Patent Right Covering such Licensed Product in such country, (such period for a particular Licensed Product in a particular country, the “Royalty Term” for such Licensed Product in such country) .

	
 
	
3.3
	
Non-cash Consideration

If Licensee receives or anticipates receipt of non-cash consideration from sales of Licensed Products or Sublicense Agreements, the manner in which Licensor will receive its compensation under the Agreement with respect to such non-cash consideration will be negotiated in good faith and timely agreed to by the Parties.

	
4.
	
Reports and Plans

The reports specified in this Section 4 will be sent to Licensor’s payment and reporting contact identified in Section 18 (Notices) of the Patent License Agreement. Any special formatting requirements for such reports shall be mutually agreed upon in writing by Licensor and Licensee.

	
 
	
4.1
	
Quarterly Payment and Milestone Reports

On or before each Quarterly Payment Deadline, Licensee will deliver to Licensor a true and accurate report, certified by an officer of Licensee, giving such particulars of the business conducted by Licensee, its Affiliates and its Sublicensees (including copies of reports provided by Sublicensees and Affiliates to Licensee) during the preceding Contract Quarter under the Agreement as necessary for Licensor to account for Licensee’s payments hereunder, even if no payments are due. The reports shall continue to be delivered after the termination or expiration of the Agreement until such time as all Licensed Products permitted to be sold after termination or expiration have been sold or destroyed. Licensee shall provide information in sufficient detail to enable the royalties payable hereunder to be determined and to calculate all of the amounts payable under the Agreement. The report shall include:

	
 
	
(a)
	
The name of the Licensee, the Patent License Agreement number, and the period covered by the report;

	
 
	
(b)
	
The name of any Affiliates and Sublicensees whose activities are also covered by the report;

	
 
	
(c)
	
Identification of each Licensed Product for which any royalty payments have become payable;

	
 
	
(d)
	
Net Product Sales segregated on a product-by-product basis, and a country-by-country basis, or an affirmative statement that no Sales were 

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made. The report shall also itemize the permitted deductions from the gross revenue used to arrive at the resulting Net Product Sales on a product-by-product basis;

	
 
	
(e)
	
The applicable royalty rate;

	
 
	
(f)
	
An affirmative statement of whether any milestones with deadlines in that Contract Quarter under Section 2.4 and any milestones under Section 3.1(b) were met or not, and the resulting Milestone Fee payable;

	
 
	
(g)
	
Non-Royalty Sublicensing Consideration received by Licensee segregated on a Sublicense Agreement -by-Sublicense Agreement basis, or an affirmative statement that none was received;

	
 
	
(h)
	
If any consideration was received in currencies other than U.S. dollars, the report shall describe the currency exchange calculations; and

	
 
	
(i)
	
Any changes in accounting methodologies used to account for and calculate the items included in the report since the previous report.

	
 
	
4.2
	
Annual Written Progress Report and Commercialization Plan

Within forty-five (45) days following the end of each Contract Year until the year following the year in which the first commercial sale of a Licensed Product occurred , Licensee will deliver to Licensor a true and accurate written progress report and commercialization plan, certified by an officer of Licensee, that summarizes (i) Licensee’s efforts and accomplishments during the Contract Year to diligently commercialize Licensed Products, and (ii) Licensee’s development and commercialization plans with respect to Licensed Products for the next Contract Year. The report shall also cover such activities by Affiliates and Sublicensees. The report shall contain the following information to the extent relevant to the activities under the Agreement:

	
 
	
(a)
	
The name of the Licensee, the Patent License Agreement number, the names of any Affiliates and Sublicensees, and the products and services being developed and/or commercialized;

	
 
	
(b)
	
The progress toward completing and the plans for completing the applicable milestone events pursuant to Sections 2.4 and 3.1(b);

	
 
	
(c)
	
The research and development activities, including status and plans for obtaining any necessary governmental approvals, performed during the past year, and the plans for research and development activities for the next year; and

	
 
	
(d)
	
The marketing activities for the past year and planned for the next year, and Licensee’s internal estimate for sales for the next year.

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5.
	
Payment, Records, and Audits

	
 
	
5.1
	
Payments

All amounts referred to in the Patent License Agreement are expressed in U.S. dollars without deductions for taxes, assessments, fees, or charges of any kind. Each payment will reference the agreement number set forth at the beginning of the Patent License Agreement. All payments to Licensor will be made in U.S. dollars by check or wire transfer (Licensee to pay all wire transfer fees) payable to the payee identified in Section 18 of the Patent License Agreement and sent to the payment and reporting contact in Section 18 (Notices) of the Patent License Agreement.

	
 
	
5.2
	
Sales Outside the U.S.

If any currency conversion shall be required in connection with the calculation of payments hereunder, such conversion shall be made using the rate used by Licensee for its financial reporting purposes in accordance with Generally Accepted Accounting Principles (or foreign equivalent) or, in the absence of such rate, using the average of the buying and selling exchange rate for conversion between the foreign currency and U.S. Dollars, for current transactions as reported in The Wall Street Journal on the last business days of the Contract Quarter to which such payment pertains. Licensee may not make any tax withholdings from payments to Licensor, but Licensor agrees to supply to Licensee, upon written request, appropriate evidence from appropriate U.S. governmental agencies showing that Licensor is a resident of the United States of America for purposes of the U.S. income tax laws and is tax-exempt under such income tax laws.

	
 
	
5.3
	
Late Payments

Undisputed amounts that are not paid when due will accrue a late charge from the due date until paid, at a rate equal to 1.0% per month (or the maximum allowed by law, if less).

	
 
	
5.4
	
Records

For a period of four years after the Contract Quarter to which the records pertain, Licensee agrees that it and its Affiliates and Sublicensees will each keep complete and accurate records of their Net Product Sales, Milestone Fees, and Non-Royalty Sublicensing Consideration in sufficient detail to enable such payments to be determined and audited.

	
 
	
5.5
	
Auditing

Licensee and its Affiliates will permit an independent certified public accountant designated by Licensor and approved in writing by Licensee (which approval shall not be unreasonably withheld or delayed), at Licensor’s expense, to examine 

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books, ledgers, and records relating solely to amounts payable hereunder, during regular business hours, at Licensee’s or its Affiliate’s place of business, on at least thirty (30) days advance notice, to the extent necessary to verify any payment required under the Agreement. For each Sublicensee, Licensee shall obtain such audit rights for Licensor or itself. If Licensee obtains such audit rights for itself, it will promptly conduct an audit of the Sublicensee’s records upon Licensor’s request and at Licensor’s expense, and Licensee will furnish to Licensor a copy of the findings from such audit. No more than one audit of Licensee, each Affiliate, and each Sublicensee shall be conducted under this Section 5.5 in any calendar year. If any amounts due Licensor have been underpaid, then Licensee shall immediately pay Licensor the amount of such underpayment plus accrued interest due in accordance with Section 5.3. If the amount of underpayment is equal to or greater than 5% of the total amount due for the records so examined, Licensee will pay the cost of such audit. Such audits may, if mutually agreed upon in writing by Licensor and Licensee, consist of a self-audit conducted by Licensee at Licensor’s expense and certified in writing by an authorized officer of Licensee. If the amounts due Licensor have been overpaid, the balance of overpayment shall be credited toward the next payment of monies owed Licensor. All information examined pursuant to this Section 5.5 shall be deemed to be the Confidential Information of the Licensee.

	
6.
	
Patent Expenses and Prosecution

	
 
	
6.1
	
Patent Expenses

Licensee shall reimburse Licensor for all past documented, out-of-pocket expenses incurred by Licensor for filing, prosecuting, enforcing, defending and maintaining Patent Rights and related patent searches through the Effective Date of the Agreement, including those identified in Section 3.1(a) of the Patent License Agreement, and all such future expenses incurred by Licensor, for so long as, and in such countries as the Agreement remains in effect. Licensee will reimburse such patent expenses, within thirty (30) days after Licensee’s receipt of an invoice, with such payment being made either directly to Prosecution Counsel or to Licensor, as elected by Licensor in writing on or before the date of the applicable invoice. Patent expense payment delinquencies (whether owed directly to Prosecution Counsel or to Licensor) that are not in dispute in good faith will be considered a payment default under Section 7.3(a).

	
 
	
6.2
	
Direction of Prosecution

Licensor will apply for, prosecute, and maintain during the term of this Agreement, the Patent Rights in the United States and in the foreign countries listed in Schedule 6.2 hereto. Licensor will confer with Licensee to develop a strategy for the prosecution and maintenance of Patent Rights. Licensor will request that copies of all documents prepared by the Prosecution Counsel for submission to governmental patent offices be provided to Licensee for review and comment prior to filing, to the extent practicable under the circumstances. 

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Licensee will be given reasonable opportunities to advise Licensor in the filing, prosecution, and maintenance of Patent Rights. At Licensee’s request, and reasonably in advance of any filing, fee, or other action deadlines, Licensee shall be provided with copies of all prosecution documents relating to Patent Rights so that Licensee may have the opportunity to offer comments and remarks thereon, such comments and remarks to be given due consideration by Licensor. At its discretion, Licensor may allow Licensee to instruct Prosecution Counsel directly, provided, that (a) Licensor will maintain final authority in all decisions regarding the prosecution and maintenance of the Patent Rights, (b) Licensor may revoke this authorization to instruct Prosecution Counsel directly at any time, and (c) the Prosecution Counsel remains counsel to the Licensor with an appropriate contract (and shall not jointly represent Licensee unless requested by Licensee and approved by Licensor, and an appropriate engagement letter and conflict waiver are in effect). If Licensee wishes to instruct Prosecution Counsel directly or change Prosecution Counsel, Licensee may request to do so by following the Licensor’s procedures for such. Licensor reserves in its sole discretion the ability to change Prosecution Counsel and to approve or disapprove any requested changes by Licensee. The Parties agree that they share a common legal interest to get valid enforceable patents and that Licensee will maintain as privileged all information received pursuant to this Section.

	
 
	
6.3
	
Ownership

All patent applications and patents will be in the name of Licensor (and any co-owner identified in Section 1 of the Patent License Agreement) and owned by Licensor (and such co-owner, if any). No payments due under the Patent License Agreement will be reduced solely as the result of co-ownership interests in the Patent Rights by Licensee or any other party.

	
 
	
6.4
	
Additional Foreign Filings

If Licensee wishes to pursue patent protection in countries other than the U.S., and the foreign countries listed in Schedule 6.2 hereto, then (i) Licensee shall notify Licensor in writing, subject to applicable bar dates, of such foreign countries in sufficient time to reasonably enable the preparation of such additional filings, (ii) Licensor will apply for, prosecute, and maintain during the term of this Agreement, the Patent Rights in such foreign countries, and (iii) Schedule 6.2 shall be automatically amended to include such foreign countries. If Licensee notifies Licensor in writing that it does not choose to pursue patent rights in a particular foreign country and Licensor chooses to do so, Licensor shall so notify Licensee and thereafter said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto.

	
 
	
6.5
	
Withdrawal from Paying Patent Costs

If at any time Licensee wishes to cease paying for any costs for a particular Patent Right or for patent prosecution in a particular jurisdiction, Licensee must give 

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Licensor at least ninety (90) days prior written notice and Licensee will continue to be obligated to pay for the patent costs which reasonably accrue during said notice period. Thereafter, said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto.

	
 
	
6.6
	
U.S. Patent and Trademark Office Entity Size Status

Licensee represents that as of the Effective Date the entity size status of Licensee in accordance with the regulations of the U.S. Patent and Trademark Office is as set forth in Section 1 of the Patent License Agreement. Licensee will inform Licensor in writing on a timely basis of any change in its U.S. Patent and Trademark Office entity size status.

	
7.
	
Term and Termination

	
 
	
7.1
	
Term

Unless earlier terminated as provided herein, the term of the Agreement will commence on the Effective Date and continue on a country-by-country and Licensed Product-by-Licensed Product basis, until the expiration of the Royalty Term for a particular Licensed Product in a particular country (with the entire Agreement expiring on the expiration of the last-to-expire Royalty Term).

	
 
	
7.2
	
Termination by Licensee

Licensee, at its option, may terminate the Agreement by providing Licensor written notice of intent to terminate, which such termination effective will be ninety (90) days following receipt of such notice by Licensor.

	
 
	
7.3
	
Termination by Licensor

Licensor, at its option, may immediately terminate the Agreement, or any part of Patent Rights, or any part of Field, or any part of Territory, or the exclusive nature of the license grant, upon delivery of written notice to Licensee of Licensor’s decision to terminate, if any of the following occur:

	
 
	
(a)
	
Licensee becomes in arrears in any payments due under the Agreement, and Licensee fails to make the required payment within thirty (30) days after delivery of written notice from Licensor; or

	
 
	
(b)
	
Licensee is in breach of any non-payment provision of the Agreement, and does not cure such breach within sixty (60) days after delivery of written notice from Licensor; or

Licensor delivers notice to Licensee of [*], even in the event that Licensee cures such breaches in the allowed period, but only if [*]; or

*Confidential Treatment Requested.

 

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(d)
	
Licensee or its Affiliate or Sublicensee participates in any proceeding or action to challenge the validity, enforceability, or scope of one or more of the Patent Rights. Provided however, this section shall not be applicable in the context of a Sublicensee or Affiliate defending against a patent infringement suit initiated by licensor, or if Licensee terminates a Sublicensee (in the event Sublicensee sues Licensor) within 30 days of receiving notice from Licensor that they are being sued by the Sublicensee.

	
 
	
7.4
	
Other Conditions of Termination

The Agreement will terminate:

	
 
	
(a)
	
Immediately without the necessity of any action being taken by Licensor or Licensee, (i) if Licensee files for bankruptcy under Chapter 7 or Chapter 11 of the U.S. Bankruptcy Act or becomes insolvent, or (ii) Licensee’s Board of Directors elects to liquidate its assets or dissolve its business, or (iii) Licensee makes an assignment for the benefit of creditors or (iv) if the business or assets of Licensee are otherwise placed in the hands of a receiver, assignee for the protection of creditors or trustee, whether by voluntary act of Licensee or otherwise; or

	
 
	
(b)
	
At any time by mutual written agreement between Licensee and Licensor.

	
 
	
7.5
	
Effect of Termination

If the Agreement is terminated for any reason:

	
 
	
(a)
	
If a Sublicensee is in good standing under its Sublicense Agreement without any uncured defaults that would otherwise have entitled the Licensee to terminate such Sublicense Agreement, the Sublicensee may request Licensor to grant a direct license to the Sublicensee on comparable terms; which request must be in writing and received by Licensor not later than thirty (30) days after any termination of the Agreement. If Licensor determines that the Sublicensee is well qualified to continue as a direct licensee, Licensor will not unreasonably withhold consent for such request; in which event, said Sublicensee and Licensor will enter into a new mutually approved written license agreement that endeavors to preserve the essential benefits for each party that they enjoyed under the prior Agreement and Sublicense Agreement. For the avoidance of doubt, during the period between the termination of the Agreement and the date on which such a mutually approved written license agreement is consummated between the Sublicensee and Licensor, the Sublicense Agreement shall be deemed to continue with the Licensor directly. If no such mutually approved written license agreement is consummated between the Sublicensee and Licensor, the Sublicense Agreement shall be deemed to be terminated.

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(b)
	
Licensee shall cease making, having made, distributing, having distributed, using, selling, offering to sell, leasing, loaning and importing any Licensed Products by the effective date of termination; and

	
 
	
(c)
	
Licensee shall tender payment of all accrued royalties and other accrued payments due to Licensor in accordance with the payment terms hereof; and

	
 
	
(d)
	
Nothing in the Agreement will be construed to release either Party from any obligation that matured prior to the effective date of termination; and

	
 
	
(e)
	
The provisions of Sections 8 (Confidentiality), 9 (Infringement and Litigation), 11 (Representations and Disclaimers), 12 (Limit of Liability), 13 (Indemnification), 14 (Insurance), 17 (Use of Name), 18 (Notices), and 19 (General Provisions) will survive any termination or expiration of the Agreement. In addition, the provisions of Sections 3 (Compensation), 4.1 (Quarterly Payment and Milestone Reports), 5 (Payment, Records and Audits), and 6.1 (Patent Expenses) shall survive with respect to all activities and payment obligations accruing prior to the termination or expiration of the Agreement.

	
8.
	
Confidentiality

	
 
	
8.1
	
Definition

“Confidential Information” means all information that is of a confidential or proprietary nature to Licensor or Licensee and provided by one Party to the other Party under the Agreement.

	
 
	
8.2
	
Protection and Marking

Licensor and Licensee each agree that all Confidential Information disclosed in tangible form, and marked “confidential” and forwarded to one by the other, or if disclosed orally, is designated as confidential at the time of disclosure: (i) is to be held in strict confidence by the receiving Party, (ii) is to be used by and under authority of the receiving Party only as authorized in the Agreement, and (iii) shall not be disclosed by the receiving Party, its agents or employees without the prior written consent of the disclosing Party or as authorized in the Agreement. Licensee has the right to use and disclose Confidential Information of Licensor reasonably in connection with the exercise of its rights under the Agreement, including without limitation disclosing to Affiliates, Sublicensees, potential investors, acquirers, and others on a need to know basis, if such Confidential Information is provided under conditions which reasonably protect the confidentiality thereof. Each Party’s obligation of confidence hereunder includes, without limitation, using at least the same degree of care with the disclosing Party’s Confidential Information as it uses to protect its own Confidential Information, but always at least a reasonable degree of care.

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8.3
	
Confidentiality of Terms of Agreement

Each Party agrees not to disclose to any third party the terms of the Agreement without the prior written consent of the other Party hereto, except each Party may disclose the terms of the Agreement: (a) to advisors, actual or potential Sublicensees, acquirers or investors, and others on a need to know basis, in each case, under appropriate confidentiality obligations substantially similar to those of this Section 8; and (b) to the extent necessary to comply with applicable laws and court orders (including, without limitation, The Texas Public Information Act, as may be amended from time to time, other open records laws, decisions and rulings, and securities laws, regulations and guidance). Notwithstanding the foregoing, the existence of the Agreement shall not be considered Confidential Information.

	
 
	
8.4
	
Disclosure Required by Court Order or Law

If the receiving Party is required to disclose Confidential Information of another Party hereto, or any terms of the Agreement, pursuant to the order or requirement of a court, administrative agency, or other governmental body or applicable law, the receiving Party may disclose such Confidential Information or terms to the extent required, provided that the receiving Party shall use reasonable efforts to provide the disclosing Party with reasonable advance notice thereof to enable the disclosing Party to seek a protective order and otherwise seek to prevent such disclosure. To the extent that Confidential Information so disclosed does not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information protected pursuant to Section 8.

	
 
	
8.5
	
Copies

Each Party agrees not to copy or record any of the Confidential Information of the other Party, except as reasonably necessary to exercise its rights or perform its obligations under the Agreement, and for archival and legal purposes.

	
 
	
8.6
	
Continuing Obligations

Subject to the exclusions listed in Section 8.7, the Parties’ confidentiality obligations under the Agreement will survive termination of the Agreement and will continue for a period of five (5) years thereafter.

	
 
	
8.7
	
Exclusions

Information shall not be considered Confidential Information of a disclosing Party under the Agreement to the extent that the receiving Party can establish by competent written proof that such information:

	
 
	
(a)
	
Was in the public domain at the time of disclosure; or

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(b)
	
Later became part of the public domain through no act or omission of the recipient Party, its employees, agents, successors or assigns in breach of the Agreement; or

	
 
	
(c)
	
Was lawfully disclosed to the recipient Party by a third party having the right to disclose it not under an obligation of confidentiality; or

	
 
	
(d)
	
Was already known by the recipient Party at the time of disclosure; or

	
 
	
(e)
	
Was independently developed by the recipient Party without use of ‘ the disclosing Party’s Confidential Information.

	
 
	
8.8
	
Copyright Notice

The placement of a copyright notice on any Confidential Information will not be construed to mean that such information has been published and will not release the other Party from its obligation of confidentiality hereunder.

	
9.
	
Infringement and Litigation

	
 
	
9.1
	
Notification

If either Licensor’s designated office for technology commercialization or Licensee becomes aware of any alleged, potential or actual infringement of Patent Rights, each Party shall promptly notify the other of such in writing. Within two (2) business days of such notification (the “SRA Notice Period”), Licensor agrees to notify Licensee in writing if the infringing party is a party to a sponsored research agreement with the Licensor [*].

*Confidential Treatment Requested.

 

	
 
	
9.2
	
Licensee’s Enforcement Rights

With respect to any potential infringement of the Patent Rights, Licensee shall have the first and primary right, but not the obligation, to, at its expense, initiate, prosecute, and control any action or legal proceedings, and/or enter into a settlement, including any declaratory judgment action, with respect thereto. In the event Licensor provides Licensee with an SRA Notice during the SRA Notice Period, Licensee shall not file an infringement lawsuit against the third party identified in such SRA Notice for at least [*] from the date of such SRA Notice. In any such litigation brought by Licensee, Licensee shall have the right to use and sue in Licensor’s name and join Licensor as a party to such litigation only with the prior written consent of Licensor, and Licensor shall cooperate reasonably with respect thereto, as requested and at the expense of Licensee. If, within one hundred eighty (180) calendar days of the notice in Section 9.1, Licensee has neither brought, nor is Licensee diligently prosecuting an infringement or other action with respect to such potential infringement, then Licensor shall have the right, at its expense, to bring suit to enforce such Patent Rights against such potential infringer, at its own expense, unless Licensee has provided Licensor with a reasonable strategic rationale for not taking action to 

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terminate such potential infringement. Notwithstanding the foregoing, Licensor shall not, and shall not permit any third party to, proceed against an alleged infringer of the Patent Rights in the Territory (1) unless significant damages are reasonably expected to be recovered from the infringer in such proceeding and (2) without first consulting with Licensee regarding the strategy for such proceeding and considering in good faith Licensee’s comments regarding such proceeding.

	
 
	
9.3
	
Litigation Control

The Party pursuing or controlling any action or defense under Section 9.2 (the “Controlling Party”) shall be free to enter into a settlement, consent judgment, or other voluntary disposition of any such action or defense, provided, however, that (i) the Controlling Party shall consult with the other Party (the “Secondary Party”) prior to entering into any settlement or voluntary disposition thereof, (ii) any settlement, consent judgment or other voluntary disposition of such actions which (1) subjects the Secondary Party to any non-indemnified liability or obligation or (2) admits fault or wrongdoing on the part of Secondary Party must, in each case, be approved in advance and in writing by the Secondary Party, (iii) any settlement, consent judgment or other voluntary disposition of such actions which materially limits the scope, validity, or enforceability of, or otherwise may adversely affect, any Patent Rights shall not be entered into, consented to, approved, or agreed upon without the other Party’s prior written approval, and (iv) any settlement, consent judgment or other voluntary disposition of such actions that would reasonably be expected to materially adversely affect the Patent Rights or the ability of Licensee to manufacture, use, market or sell Licensed Products shall not be entered into, consented to, approved, or agreed upon without Licensee’s prior written consent. With respect to clause (ii) or (iii) above in this Section 9.3, the Secondary Party shall provide the Controlling Party notice of its approval or denial of such approval within [*] business days of any request for such approval by the Controlling Party, provided that (X) in the event Secondary Party wishes to deny such approval, such notice shall include a written description summarizing the Secondary Party’s reasonable objections to the proposed settlement, consent judgment, or other voluntary disposition and (Y) Secondary Party shall be deemed to have approved such proposed settlement, consent judgment, or other voluntary disposition in the event it fails to provide such notice within such [*] business day period.

*Confidential Treatment Requested.

 

	
 
	
9.4
	
Sharing Net Recovery

 Any recovery or damages received by the Controlling Party with respect to the infringement of the rights to the Patent Rights granted under this Agreement, or in settlement of any matter subject to Section 9.2 shall (i) first be used to reimburse the Parties pro rata for unreimbursed reasonable, documented litigation expenses (excluding, with respect to any costs or expenses incurred by Licensor, compensation of any employees or consultants of Licensor or any Affiliate thereof) incurred in connection with such action or settlement, and the remainder shall be split [*] to Controlling Party and [*] to Secondary Party. Notwithstanding 

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the foregoing, the Secondary Party, at its expense, shall have the right to be represented by counsel of its choice in any proceeding governed by this Section.

*Confidential Treatment Requested.

 

	
10.
	
Export Compliance

Licensee understands that the Arms Export Control Act (AECA), including its implementing International Traffic In Arms Regulations (ITAR), and the Export Administration Act (EAA), including its Export Administration Regulations (EAR), are some (but not all) of the laws and regulations that comprise the U.S. export laws and regulations. Licensee further understands that the U.S. export laws and regulations include (but are not limited to): (a) ITAR and EAR product/service/data-specific requirements; (b) ITAR and EAR ultimate destination-specific requirements; (c) ITAR and EAR end user-specific requirements; (d) Foreign Corrupt Practices Act; and (e) anti-boycott laws and regulations. Licensee will comply with all then-current applicable export laws and regulations of the U.S. Government (and other applicable U.S. laws and regulations) pertaining to the Licensed Products (including any associated products, items, articles, computer software, media, services, technical data, and other information). Licensee certifies that it will not, directly or indirectly, export (including any deemed export), nor re-export (including any deemed re-export) the Licensed Products (including any associated products, items, article’s, computer software, media, services, technical data, and other information) in violation of applicable U.S. laws and regulations. Licensee will include a provision in its agreements, substantially similar to this Section 10, with its Sublicensees, third party wholesalers and distributors, and physicians, hospitals or other healthcare providers who purchase a Licensed Product, requiring that these parties comply with all then-current applicable U.S. export laws and regulations and other applicable U.S. laws and regulations.

	
11.
	
Representations and Disclaimers

	
 
	
11.1
	
Licensor Representations

Except for the rights, if any, of the Government as set forth in Section 11.2, Licensor represents and warrants to Licensee that to the knowledge of Licensor’s Office of Technology Commercialization (i) Licensor is the owner of the entire right, title, and interest in and to Patent Rights (other than the right, title and interest of any joint owner identified in Section 1 of the Patent License Agreement), (ii) Licensor has the right to grant licenses hereunder, (iii) Licensor has not knowingly granted and will not knowingly grant licenses or other rights under the Patent Rights that are in conflict with the terms and conditions in the Agreement, (iv) Licensor’s execution and performance of this Agreement will not result in a breach of any other contract to which it is, or will become, a party, and (v) OTC has not received any written notification, alleging that the Patent Rights are invalid or unenforceable or that the exercise by Licensee of any rights granted hereunder will infringe on or constitute misappropriation of any patent or other proprietary right of any third party.

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11.2
	
Government Rights

Licensee understands that Patent Rights may have been developed under a funding agreement with Government and, if so, that Government may have certain rights relative thereto. The Agreement is made subject to the Government’s rights under any such agreement and under any applicable Government law or regulation. To the extent that there is a conflict between any such agreement, such applicable law or regulation and the Agreement, the terms of such Government agreement, and applicable law or regulation, shall prevail. Licensee agrees that, to the extent required by U.S. laws and regulations, Licensed Products used or sold in the U.S. will be manufactured substantially in the U.S., unless a written waiver is obtained in advance from the U.S. Government.

	
 
	
11.3
	
Licensor Disclaimers

EXCEPT AS SPECIFICALLY SET FORTH IN SECTION 11.1, LICENSEE UNDERSTANDS AND AGREES THAT LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, AS TO THE LICENSED PRODUCTS OR LICENSED SERVICES, OR AS TO THE OPERABILITY OR FITNESS FOR ANY USE OR PARTICULAR PURPOSE, MERCHANTABILITY, SAFETY, EFFICACY, APPROVABILITY BY REGULATORY AUTHORITIES, TIME AND COST OF DEVELOPMENT, PATENTABILITY, AND/OR BREADTH OF PATENT RIGHTS. LICENSOR MAKES NO REPRESENTATION AS TO WHETHER ANY PATENT WITHIN PATENT RIGHTS IS VALID, OR AS TO WHETHER THERE ARE ANY PATENTS NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY LICENSOR THAT MIGHT BE REQUIRED FOR USE OF PATENT RIGHTS IN FIELD. NOTHING IN THE AGREEMENT WILL BE CONSTRUED AS CONFERRING BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS TO ANY PATENTS OR TECHNOLOGY OF LICENSOR OTHER THAN THE PATENT RIGHTS, WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO THE PATENT RIGHTS. LICENSOR HAS NO OBLIGATION TO FURNISH TO LICENSEE ANY KNOW-HOW, TECHNOLOGY OR TECHNOLOGICAL INFORMATION.

	
 
	
11.4
	
Licensee Representation

By execution of the Agreement, Licensee represents, acknowledges, covenants and agrees (a) that Licensee has not been induced in any way by Licensor or its employees to enter into the Agreement, and (b) that Licensee has been given an opportunity to conduct sufficient due diligence with respect to all items and issues pertaining to this Section 11 (Representations and Disclaimers) and all other matters pertaining to the Agreement; and (c) that Licensee has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and (d) that Licensee accepts all risks 

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inherent herein. Licensee represents that it is a duly organized, validly existing entity of the form indicated in Section 1 of the Patent License Agreement, and is in good standing under the laws of its jurisdiction of organization as indicated in Section 1 of the Patent License Agreement, and has all necessary corporate or other appropriate power and authority to execute, deliver and perform its obligations hereunder.

	
12.
	
Limit of Liability

IN NO EVENT SHALL LICENSOR, THE UNIVERSITY SYSTEM IT GOVERNS, ITS MEMBER INSTITUTIONS, INVENTORS, REGENTS, OFFICERS, EMPLOYEES, STUDENTS, AGENTS OR AFFILIATED ENTERPRISES (COLLECTIVELY, “LICENSOR COVERED PARTIES”), BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER ANY SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES.

OTHER THAN FOR CLAIMS AGAINST LICENSEE FOR INDEMNIFICATION PROVIDED UNDER SECTION 13 WITH RESPECT TO THIRD PARTY CLAIMS, IN NO EVENT SHALL LICENSEE, ITS AFFILIATES OR SUBLICENSEES BE LIABLE TO LICENSOR COVERED PARTIES FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER LICENSEE KNOWS OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.

	
13.
	
Indemnification

	
 
	
13.1
	
Indemnification Obligation

Subject to Section 13.2, Licensee agrees to hold harmless, defend and indemnify Licensor, the university system it governs, its member institutions, its Regents, officers, employees, students and agents (the “Indemnified Parties”, or an “Indemnified Party”) from and against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees and other expenses of litigation) (collectively “Liabilities”) resulting from claims or demands brought by third parties against an Indemnified Party on account of any injury or death of persons, damage to property, or any other damage or loss arising out of the exercise or practice by or under authority of Licensee, its Affiliates or their Sublicensees, or third party wholesalers or distributors, or physicians, hospitals or other healthcare providers who purchase a Licensed Product, of the rights granted hereunder.

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13.2
	
Conditions of Indemnification

Licensee shall have no responsibility or obligation under Section 13.1 for any Liabilities to the extent caused by the gross negligence or willful misconduct by an Indemnified Party. Obligations to indemnify, and hold harmless under Section 13.1 are subject to: (a) to the extent authorized by the Texas Constitution and the laws of the State of Texas, and subject to the statutory duties of the Texas Attorney General, the Indemnified Party giving Licensee control of the defense and settlement of the claim and demand; and (b) to the extent authorized by the Texas Constitution and the laws of the State of Texas and subject to statutory duties of the Texas Attorney General, the Indemnified Party providing assistance reasonably requested by Licensee, at Licensee’s expense.

	
14.
	
Insurance

	
 
	
14.1
	
Insurance Requirements

Prior to any Licensed Product being used in humans or sold (including for the purpose of obtaining regulatory approvals), by Licensee, an Affiliate, or by a Sublicensee, and for a period of five years after the Agreement expires or is terminated, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance or an equivalent program of self-insurance in commercially reasonable and appropriate amounts for the Licensed Product being used or sold. Licensee shall use commercially reasonable efforts to have Licensor named as an additional insured party. Such commercial general liability insurance shall provide, without limitation: (i) product liability coverage; (ii) broad form contractual liability coverage for Licensee’s indemnification under the Agreement; and (iii) coverage for litigation costs.

	
 
	
14.2
	
Evidence of Insurance and Notice of Changes

Upon request by Licensor, Licensee shall provide Licensor with written evidence of such insurance. Additionally, Licensee shall provide Licensor with written notice of at least 30 days prior to Licensee cancelling, not renewing, or materially changing such insurance.

	
15.
	
Assignment

*Confidential Treatment Requested.

 
The Agreement may not be assigned by Licensee without the prior written consent of Licensor, which consent will not be unreasonably withheld; provided, however, that Licensee shall be permitted to assign this Agreement to (i) any of its Affiliates, [*]. A Change of Control shall be considered an assignment of the Agreement. For any permitted assignment to be effective, (a) the Licensee must be in good standing under this Agreement, (b) the assignment fee, if applicable, shall be payable as specified in Section 3.1(e) of the Agreement (c) the assignee must assume in writing all of Licensee’s interests, rights, duties and obligations under the Agreement and agree to comply with all terms and conditions of the Agreement as if the assignee were an original Party to the Agreement and, (d) provide written notice to the Licensor of such assignment no less
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than 15 days after completion of such assignment. Any such assignment must be of all rights and obligations of Licensee, such that there is only one existing Licensee at any one time.

	
16.
	
Governmental Markings

	
 
	
16.1
	
Patent Markings

To the extent reasonably practical, Licensee agrees to mark, and shall use commercially reasonable efforts to ensure that its Affiliates, licensees, and sublicensees mark, all Licensed Products with the number of any applicable patent(s) licensed hereunder as part of the Patent Rights in accordance with each country’s patent marking laws, including Title 35, U.S. Code, or if such marking is not practicable, shall so mark the accompanying outer box or product insert for Licensed Products accordingly.

	
 
	
16.2
	
Governmental Approvals and Marketing of Licensed Products

Licensee will be responsible for obtaining all necessary Governmental approvals for the development, production, distribution, sale, and use of any Licensed Product, at Licensee’s expense, including, without limitation, any safety studies. Licensee will have sole responsibility for any warning labels, packaging and instructions as to the use and the quality control for any Licensed Product.

	
 
	
16.3
	
Foreign Registration and Laws

Licensee agrees to register the Agreement with any foreign governmental agency that requires such registration; and Licensee will pay all costs and legal fees in connection with such registration. Licensee is responsible for compliance with all foreign laws affecting the Agreement or the Sale of Licensed Products to the extent there is no conflict with United States law, in which case United States law will control.

	
17.
	
Use of Name

Licensee will not use the name, trademarks or other marks of Licensor (or the name of the university system it governs, its member institutions, any of its Regents or employees) without the advance written consent of Licensor; provided however, in connection with describing the Agreement to existing and prospective investors and Sublicensees, Licensee may identify Licensor’s name as the licensor. Licensor may use Licensee’s name and logo for annual reports, brochures, website, and internal reports without prior consent.

	
18.
	
Notices

Any notice or other communication of the Parties required or permitted to be given or made under the Agreement will be in writing and will be deemed effective when sent in a manner that provides confirmation or acknowledgement of delivery and received at the 

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address set forth in Section 18 of the Patent License Agreement (or as changed by written notice pursuant to this Section 18). Notices required under the Agreement may be delivered via E-mail provided such notice is confirmed in writing as indicated.

Notices shall be provided to each Party as specified in the “Contact for Notice” address set forth in Section 18 of the Patent License Agreement. Each Party shall update the other Party in writing with any changes in such contact information.

	
19.
	
General Provisions

	
 
	
19.1
	
Binding Effect

The Agreement is binding upon and inures to the benefit of the Parties hereto, their respective executors, administrators, heirs, permitted assigns, and permitted successors in interest.

	
 
	
19.2
	
Construction of Agreement

Headings are included for convenience only and will not be used to construe the Agreement. The Parties acknowledge and agree that both Parties substantially participated in negotiating the provisions of the Agreement; therefore, both Parties agree that any ambiguity in the Agreement shall not be construed more favorably toward one Party than the other Party, regardless of which Party primarily drafted the Agreement.

	
 
	
19.3
	
Counterparts and Signatures

The Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument. A Party may evidence its execution and delivery of the Agreement by transmission of a signed copy of the Agreement via facsimile or email.

	
 
	
19.4
	
Compliance with Laws

Licensee will comply with all applicable federal, state and local laws and regulations, including, without limitation, all export laws and regulations.

	
 
	
19.5
	
Governing Law

The Agreement will be construed and enforced in accordance with laws of the U.S. and the State of Texas, without regard to choice of law and conflicts of law principles.

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19.6
	
Modification

Any modification of the Agreement will be effective only if it is in writing and signed by duly authorized representatives of both Parties. No modification will be made by email communications.

	
 
	
19.7
	
Severability

If any provision hereof is held to be invalid, illegal or unenforceable in any jurisdiction, the Parties hereto shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties, and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such other provisions in any other jurisdiction, so long as the essential essence of the Agreement remains enforceable.

	
 
	
19.8
	
Third Party Beneficiaries

Nothing in the Agreement, express or implied, is intended to confer any benefits, rights or remedies on any entity, other than the Parties and their permitted successors and assigns. However, if there is a joint owner of any Patent Rights identified in Section 1 of the Patent License Agreement (other than Licensee), then Licensee hereby agrees that the following provisions of these Terms and Conditions extend to the benefit of the co-owner identified therein (excluding the Licensee to the extent it is a co-owner) as if such co-owner was identified in each reference to the Licensor but only if such co-owner is bound by all of Licensor’s obligations under this Agreement: the retained rights under clause (b) of Section 2.1; Section 11.3 (Licensor Disclaimers); Section 12 (Limitation of Liability); Section 13 (Indemnification); Section 14.1 (Insurance Requirements); Section 17 (Use of Name); and Section 19.10 (Sovereign Immunity, if applicable).

	
 
	
19.9
	
Waiver

Neither Party will be deemed to have waived any of its rights under the Agreement unless the waiver is in writing and signed by such Party. No delay or omission of a Party in exercising or enforcing a right or remedy under the Agreement shall operate as a waiver thereof.

	
 
	
19.10
	
Sovereign Immunity

Nothing in the Agreement shall be deemed or treated as any waiver of Licensor’s sovereign immunity.

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19.11
	
Entire Agreement

The Agreement constitutes the entire Agreement between the Parties regarding the subject matter hereof, and supersedes all prior written or verbal agreements, representations and understandings relative to such matters.

	
 
	
19.12
	
Claims Against Licensor for Breach of Agreement

Licensee acknowledges that any claim for breach of the Agreement asserted by Licensee against Licensor shall be subject to Chapter 2260 of the Texas Government Code and that the process provided therein shall be Licensee’s sole and exclusive process for seeking a remedy for any and all alleged breaches of the Agreement by Licensor or the State of Texas.

	
 
	
19.13
	
Grant of Security. Interest

Licensee hereby grants to Licensor a security interest in and to Licensee’s rights under the Patent License Agreement, as collateral security for the payment by Licensee of any and all sums which may be owed from time to time by Licensee to Licensor. Licensor shall have all rights of a secured party as specified in the Texas Uniform Commercial Code relative to this security interest and the enforcement thereof. Licensee hereby authorizes Licensor to file with the appropriate governmental agencies appropriate UCC-1 financing statements to evidence this security interest.

— END OF EXHIBIT A —

 

 

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Schedule 6.2

*Confidential Treatment Requested.

 

[*]

 

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Schedule 20.2

				
	

Docket No.
	

Title
	
Application No.
	
Registration No.

	
AEG545/4-002US 

US
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
12/610,685
	
8,440,184

	
AEG545/4-002REUS 

US
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
14/711,916 (Reissue of 12/610685)
	
 

	
AEG545/4-002CONUS 

US
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
13/863,448
	
9,050,340

	
AEG545/4-002CON2US

US
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
14/275,259
	
 

	
AEG545/4-002CON3US

US
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
15/270,955
	
 

	
AEG545/4-002CA 

Canada
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
2742497
	
 

	
AEG545/4-002EP

Europe
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002CH

Switzerland
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002DE

Germany
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1 (DE 6020090375 82.2)
	
2350273

	
AEG545/4-002DK

Denmark
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002DIVEP

Europe
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
16163214.6
	
 

	
AEG545/4-002ES

Spain
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002FR

France
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002GB

United Kingdom
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002HK

Hong Kong (EP)
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
12100429.7
	
2350273

	
AEG545/4-002IE

Ireland
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-00211

Italy
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002JP

Japan
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
2011-534855
	
5695570

	
AEG545/4-002NL

Netherlands
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002ND

Norway
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002PL

Poland
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002SE

Sweden
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
09824219.1
	
2350273

	
AEG545/4-002TR

Turkey
	
Compositions of Engineered Human Arginases and Methods for Treating Cancer
	
TR

2016/07968
	
2350273

	
 
	
 
	
 
	
 

	
AEG545/4-003US

US
	
Methods for Purifying Pegylated Arginase
	
13/380,776
	
8,679,479

	
 
	
 
	
 
	
 

	
AEG545/4-004US

US
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
13/020,268
	
8,709,407

	
AEG545/4-004DIVUS 

US
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
14/225,518
	
9,279,119

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

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US 4915892v.1

 

				
	

Docket No.
	

Title
	
Application No.
	
Registration No.

	
AEG545/4-004DIV2US

US
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
15/052,978
	
 

	
AEG545/4-004AU

Australia
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
2011212885
	
2011212885

	
AEG545/4-004CA

Canada
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
2788689
	
 

	
AEG545/4-004CN

China
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
201180013307.X
	
 

	
AEG545/4-004EP

Europe
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
11740355.0
	
 

	
AEG545/4-004HK

Hong Kong (CN)
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
13106011.7
	
 

	
AEG545/4-0041P

Japan
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
2012-552084
	
5875990

	
AEG545/4-004KR

Korea
	
Engineered Enzymes with Methionine-Gamma-Lyase Enzymes and Pharmacological Preparations Thereof
	
10-2012-7023176
	
 

 

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinSchedule 20.2-2Agreement No. PM1401501

US 4915892v.1

 

AMENDMENT #1 TO AMENDED AND RESTATED PATENT LICENSE AGREEMENT

This Amendment #1 to Amended and Restated Patent License Agreement (as defined below) is made and entered into as of the date of last signature below (“Amendment Effective Date”) by and between Aeglea BioTherapeutics Inc., a Delaware corporation, with its principal place of business at 901 S. MoPac Expressway, Barton Oaks Plaza One, Suite 250, Austin, Texas 78746 (“Licensee”) and the University of Texas at Austin, on behalf of the Board of Regents of the University of Texas System, a not-for-profit organization and agency of the State of Texas, having its principal place of business at 2935 W. Braker Lane, Suite 1.9A (R3500), Austin, Texas 78759 (“Licensor”), each a “Party” and collectively, “Parties”.

Background

A.  Licensor and Licensee entered into an Amended and Restated Patent License Agreement (UTA No. PM1401501) with an Effective Date of January 31st, 2017 (“ARPLA”). Capitalized terms used herein without definition shall have meanings given to them in the ARPLA.

B.  Licensor and Licensee wish to amend the ARPLA as set forth below in order to (i) add in Licensee’s business address and place of incorporation and (ii) update the list of Patent Rights;

NOW, THEREFORE, in consideration of the mutual covenants and promises herein contained, the Parties hereby agree as follows:

	
 
	
1.
	
In Section 1 of the ARPLA, the name of Licensee shall be deleted in its entirety and replaced by the following: Aeglea Biotherapeutics, Inc., a Delaware corporation, with its principal place of business at 901 S. MoPac Expressway, Barton Oaks Plaza One, Suite 250, Austin, Texas 78746.

	
 
	
2.
	
In Section 1 of the ARPLA, the Patent Rights table should be deleted in its entirety and replaced with the following:

						
	
Patent Rights
	
	
App. No./
Date of Filing
	
Title
	
Inventor(s)
	
Jointly Owned? (Y/N; if Y, with whom?)
	
Prosecution Counsel

	
US61/871,727

 

filed 8/29/2013
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
US61/948,106

 

filed 3/05/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

Licensee:  Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 1Agreement No. PA1401502

 

*Confidential Treatment Requested.

 

						
	
US14/472,779

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
South Korea 10-2016-7008299

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
PCT/US2014/0 53374

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO) 
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
JP

2016-537886

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
Israel 244263

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
Europe 14839001.6

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
China 201480054224.9

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
Canada 2,922,557

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
Australia 2014312168

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents

(6337 GEO)
	
George Georgiou
Everett M. Stone
	
No
	
Parker Highlander PLLC

	
US 61/871,768

 

filed 8/29/2013
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
US 14/472,750

 

Issued as 9,481,877

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

Licensee:  Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 2Agreement No. PA1401502

 

*Confidential Treatment Requested.

 

						
	
US 15/297,102

 

Issued as 9,624,484

 

filed 10/18/2016
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
US 15/451,349

 

filed 3/06/2017
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
South Korea 10-2016-7007045

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
PCT/US2014/0 53359

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
JP

2016-537882

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
Israel 244261

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
Europe 14841106.9

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
China 201480050681.0

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

Licensee:  Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 3Agreement No. PA1401502

 

*Confidential Treatment Requested.

 

						
	
Canada 2,922,550

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
Australia 2014312159

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes

(6314 GEO)
	
George Georgiou
Everett M. Stone
Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
[*]

 
	
[*]

 
	
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Licensee:  Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 4Agreement No. PA1401502

 

*Confidential Treatment Requested.

 

IN WITNESS THEREOF, Licensor and Licensee have entered into this Amendment effective as of the Amendment Effective Date.

		
	
THE UNIVERSITY OF TEXAS AT AUSTIN ON BEHALF OF THE BOARD OF REGENTS
OF THE UNIVERSITY OF TEXAS SYSTEM

 

 

 

By:  /s/ Daniel W. Sharp, J.D.
Daniel W. Sharp, J.D.

Associate Vice President for Research and Director, Office of Technology Commercialization

 

Date: 8/4/17
	
Aeglea BioTherapeutics, Inc.

 

 

 

 

 

By: /s/ Anthony Quinn
Anthony Quinn, Ph.D.

CEO

 

Date: 10 August 2017

 

Licensee:  Aeglea BioTherapeutics, Inc.CONFIDENTIALExclusive PLA

The University of Texas at AustinPage 5Agreement No. PA1401502

 

 

 

AMENDMENT #2 TO AMENDED AND RESTATED PATENT LICENSE AGREEMENT

This Amendment #2 (the “Amendment”) to the Amended and Restated Patent License Agreement (as defined below) is made and entered into as of the date of last signature below (“Amendment Effective Date”) by and between Aeglea BioTherapeutics, Inc., a Delaware corporation, with its principal place of business at 901 S. MoPac Expressway, Barton Oaks Plaza One, Suite 250, Austin, Texas 78746 (“Licensee”) and the University of Texas at Austin, on behalf of the Board of Regents of the University of Texas System, having its principal place of business at 2935 W. Braker Lane, Suite 1.9A (R3500), Austin, Texas 78759 (“Licensor”), each a “Party” and collectively, “Parties”.

Background

A.Licensor and Licensee entered into an Amended and Restated Patent License Agreement (UTA No. PM1401501) with an Effective Date of January 31, 2017, as amended by Amendment #1 (UTA No. PA1401502) effective as of August 10, 2017 (collectively, the “ARPLA”);

B.Licensor and Licensee wish to amend the ARPLA as set forth below in order to revise the diligence milestone deadlines;

NOW, THEREFORE, in consideration of the mutual covenants and promises herein contained, the Parties hereby agree as follows:

	
 
	
1.
	
Intent. Except as expressly provided in this Amendment, the ARPLA will remain unchanged and in full force and effect in accordance with its original terms. Capitalized terms used herein without definition shall have meanings given to them in the ARPLA.

	
 
	
2.
	
Section 2.4. Section 2.4 (Diligence Milestones table) of the ARPLA is hereby deleted and replaced with the following:

					
	
2.4
	
Diligence Milestones
	

1

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALAmd. To ARPLA

The University of Texas at AustinAgreement No. PM1401503

 

*Confidential Treatment Requested.

 

	
 
	
Diligence Milestones and deadlines
(see Section 20.1)
	
Diligence Milestones
	
Deadlines

	
[*]

 
	
[*]

 

	
[*]

 
	
[*]

 

	
[*]

 
	
[*]

 

	
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2

Licensee: Aeglea BioTherapeutics, Inc.CONFIDENTIALAmd. To ARPLA

The University of Texas at AustinAgreement No. PM1401503

 

*Confidential Treatment Requested.

EXHIBIT 10.12

IN WITNESS THEREOF, Licensor and Licensee have entered into this Amendment effective as of the Amendment Effective Date.

		
	
THE UNIVERSITY OF TEXAS AT AUSTIN ON BEHALF OF THE BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM

 

 

 

/s/ Daniel W. Sharp, J.D.
Daniel W. Sharp, J.D.

Associate Vice President for Research and Director, Office of Technology Commercialization

 

Date: 12/20/2017
	
Aeglea BioTherapeutics, Inc.

 

 

 

 

 

/s/ Anthony Quinn
Anthony Quinn, M.B Ch.B, Ph.D., FRCP

Interim Chief Executive Officer

 

 

 

Date: 12/20/2017

 

 

 

AMENDMENT #3 TO AMENDED AND RESTATED PATENT LICENSE AGREEMENT

This Amendment #3 (“Amendment”) to the ARPLA (as defined below) is made and entered into as of the date of last signature below (“Amendment Effective Date”) by and between Aeglea BioTherapeutics Inc., a Delaware corporation, with its principal place of business at 901 S. MoPac Expressway, Barton Oaks Plaza One, Suite 250, Austin, Texas 78746 (“Licensee”) and the University of Texas at Austin, on behalf of the Board of Regents of the University of Texas System, an agency of the State of Texas, having its principal place of business at 2935 W. Braker Lane, Suite 1.9A (R3500), Austin, Texas 78759 (“Licensor”), each a “Party” and collectively, “Parties”.

Background

A.  Licensor and Licensee entered into an Amended and Restated Patent License Agreement (UTA No. PM1401501) effective as of January 31st, 2017, as amended by Amendment #1 (UTA No. PA1401502) effective as of August 10, 2017 and Amendment #2 (UTA No. PA1401503) effective as of December 20, 2017 (collectively, the “ARPLA”). 

B.  Licensor and Licensee wish to amend the ARPLA as set forth below in order to update the list of Patent Rights and reference an additional sponsored research agreement between the Parties; 

NOW, THEREFORE, in consideration of the mutual covenants and promises herein contained, the Parties hereby agree as follows:

	
 
	
1.
	
Intent.  Except as expressly provided in this Amendment, the ARPLA will remain

unchanged and in full force and effect in accordance with its original terms. Capitalized

terms used herein without definition shall have meanings given to them in the ARPLA.

	
 
	
2.
	
Section 1, Patent Rights Table. In Section 1 of the ARPLA, the Patent Rights table shall be deleted in its entirety and replaced with the following:

					
	
Patent Rights

	
App. No./

Date of Filing
	
Title
	
Inventor(s)
	
Jointly Owned? (Y/N; if Y, with whom?)
	
Prosecution Counsel

	
US 61/871,727

 

filed 8/29/2013
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
 No
	
Parker Highlander PLLC

	
US 61/948,106 

 

filed 3/05/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
 No
	
Parker Highlander PLLC

 

	
Licensee: Aeglea BioTherapeutics, Inc.
	
4
	
Exclusive PLA

	
The University of Texas at Austin
	
CONFIDENTIAL
	
Agreement No. PM1401501

	
US 4915892v.1
	
 
	
 

	
 
	
 
	
.

 

 

					
	
US 14/472,779 

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
 No
	
Parker Highlander PLLC

	
South Korea 10-2016-7008299 

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
  No
	
Parker Highlander PLLC

	
PCT/US2014/053374 

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
  No
	
Parker Highlander PLLC

	
JP 

2016-537886

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
  No
	
Parker Highlander PLLC

	
Israel 244263 

 

filed 8/29/2014

 
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
  No
	
Parker Highlander PLLC

	
Europe 14839001.6 

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
 No
	
Parker Highlander PLLC

	
China 201480054224.9 

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
 No
	
Parker Highlander PLLC

	
Canada 2,922,557 

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
  No
	
Parker Highlander PLLC

	
Australia 2014312168 

 

filed 8/29/2014
	
Engineered Primate Cystine/Cysteine Degrading Enzymes as Antineogenic Agents 

(6337 GEO)
	
George Georgiou

Everett M. Stone
	
  No
	
Parker Highlander PLLC

	
US 61/871,768 

 

filed 8/29/2013
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
  No
	
Parker Highlander PLLC

	
US 14/472,750 

 

Issued as 9,481,877

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
  No
	
Parker Highlander PLLC

 

	
Licensee: Aeglea BioTherapeutics, Inc.
	
5
	
Exclusive PLA

	
The University of Texas at Austin
	
CONFIDENTIAL
	
Agreement No. PM1401501

	
US 4915892v.1
	
 
	
 

	
 
	
 
	
.

 

 

					
	
US 15/297,102

Issued as 9,624,484filed 10/18/2016
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
US 15/451,349

 

filed 3/06/2017
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
South Korea 10-2016-7007045 

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
  No
	
Parker Highlander PLLC

	
PCT/US2014/053359 

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
 No
	
Parker Highlander PLLC

	
JP 

2016-537882

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
  No
	
Parker Highlander PLLC

	
Israel 244261 

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
 No
	
Parker Highlander PLLC

	
Europe 14841106.9 

filed 8/29/2014

 

Issued as 3039139 on 10/10/2018
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
 No
	
Parker Highlander PLLC

	
China 201480050681.0 

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
 No
	
Parker Highlander PLLC

	
Canada 2,922,550 

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
  No
	
Parker Highlander PLLC

 

	
Licensee: Aeglea BioTherapeutics, Inc.
	
6
	
Exclusive PLA

	
The University of Texas at Austin
	
CONFIDENTIAL
	
Agreement No. PM1401501

	
US 4915892v.1
	
 
	
 

	
 
	
 
	
.

 

 

					
	
Australia 

2014312159 

 

filed 8/29/2014
	
Engineered Primate L-Methionase for Therapeutic Purposes 

(6314 GEO)
	
George Georgiou

Everett M. Stone

Wei-Cheng Lu
	
  No
	
Parker Highlander PLLC

	
US Provisional 62/505,527

 

filed 5/12/2017
	
Engineered Primate Cystine/Cysteine Degrading Enzymes For Therapeutic Uses 

(6848 GEO)
	
George Georgiou

Everett M. Stone

Shira Cramer
	
 No
	
Parker Highlander PLLC

	
US 15/977,246

 

Filed 5/11/2018
	
Engineered Primate Cystine/Cysteine Degrading Enzymes For Therapeutic Uses 

(6848 GEO)
	
George Georgiou

Everett M. Stone

Shira Cramer
	
No
	
Parker Highlander PLLC

	
PCT application

PCT/US2018/032286

 

Filed 5/11/2018
	
Engineered Primate Cystine/Cysteine Degrading Enzymes For Therapeutic Uses

(6848 GEO)
	
George Georgiou

Everett M. Stone

Shira Cramer
	
No
	
Parker Highlander PLLC

	
US Provisional 62/359,018 

 

filed 7/06/2016
	
Human-Enzyme Mediated, Depletion of Cystine for Treating Patients with Cystinuria 

(6961 STO)
	
Everett M. Stone
	
 No
	
Parker Highlander PLLC

	
US 15/643,436

 

filed 7/06/2017
	
Human-Enzyme Mediated, Depletion of Cystine for Treating Patients with Cystinuria 

(6961 STO)
	
Everett M. Stone
	
 No
	
Parker Highlander PLLC

	
PCT application

PCT/US2017/040897  

 

filed 7/06/2017
	
Human-Enzyme Mediated, Depletion of Cystine for Treating Patients with Cystinuria 

(6961 STO)
	
Everett M. Stone
	
 No
	
Parker Highlander PLLC

	
US Provisional

62/505,493

 

filed 5/12/2017
	
Human-Enzyme Mediated, Depletion of Homocysteine for Treating Patients with Homocysteinemia/Homocystinuria

(7078 STO)
	
Everett M. Stone

George Georgiou
	
No
	
Parker Highlander PLLC

	
PCT application

PCT/US2018/032246

 

filed 5/11/2018
	
Human-Enzyme Mediated Depletion Of Homocysteine For Treating Patients With Hyperhomocysteinemia And Homocystinuria

(7078 STO)
	
Everett M. Stone

George Georgiou

Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

	
US 15/977,299

 

filed 5/11/2018
	
Human-Enzyme Mediated Depletion Of Homocysteine For Treating Patients With Hyperhomocysteinemia And Homocystinuria

(7078 STO)
	
Everett M. Stone

George Georgiou

Wei-Cheng Lu
	
No
	
Parker Highlander PLLC

 

	
Licensee: Aeglea BioTherapeutics, Inc.
	
7
	
Exclusive PLA

	
The University of Texas at Austin
	
CONFIDENTIAL
	
Agreement No. PM1401501

	
US 4915892v.1
	
 
	
 

	
 
	
 
	
.

 

 

					
	
US Provisional

62/751,197

 

filed 10/26/2018
	
ENGINEERED PRIMATE CYSTINE/CYSTEINE DEGRADING ENZYMES FOR THERAPEUTIC USES 

(7387 STO)
	
Everett M. Stone

Wei-Cheng Lu

Christos Karamitros
	
No
	
Parker Highlander PLLC

 

	
 
	
3.
	
Section 20.3.  Section 20.3 of the ARPLA shall be deleted in its entirety and replaced by the following: 

20.3  If the Parties mutually determine that the rights granted by this Patent License Agreement are essential to the Licensee’s use of any University Invention arising under Sponsored Research Agreement UTA13-001113 or Sponsored Research Agreement UTA18-001200, then such University Invention shall be included in this Patent License Agreement, upon Licensee’s payment to Licensor of a fee of $10,000.

 

[SIGNATURE PAGE TO FOLLOW]

 

 

 

IN WITNESS THEREOF, Licensor and Licensee have entered into this Amendment effective as of the Amendment Effective Date.

		
	
 

THE UNIVERSITY OF TEXAS AT AUSTIN ON BEHALF OF THE BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM

 

 

 

By: /s/ Les Nichols

Les Nichols

Interim Director 

Office of Technology Commercialization

 

Date: 11/27/2018
	
 

AEGLEA BIOTHERAPEUTICS, INC

 

 

 

 

 

By: /s/ Anthony Quinn

Anthony Quinn, Ph.D.

CEO

 

Date: 12/6/18

 

 

	
Licensee: Aeglea BioTherapeutics, Inc.
	
8
	
Exclusive PLA

	
The University of Texas at Austin
	
CONFIDENTIAL
	
Agreement No. PM1401501

	
US 4915892v.1
	
 
	
 

	
 
	
 
	
.agle-ex1018_838.htm

FDB Global MSA December 2017EXHIBIT 10.18

	
 
	
[*]
	
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 Exchange Act of 1934, as amended.

DATED                                                                                          November 7, 2018

 

 

 

 

 

 

(1)  FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED

 

 

(2)  FUJIFILM DIOSYNTH BIOTECHNOLOGIES TEXAS, LLC

 

 

(3)  FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A., INC

 

 

AND

 

 

(4)  AEGLEA BIOTHERAPEUTICS, INC.

 

 

 

 

 

 

 

 

 

 

MASTER SERVICES AGREEMENT 

 

 

FDB Global MSA December 2017

CONTENTS

 

 

1.Definitions and Interpretation1

2.Appointment of Fujifilm7

3.Term8

4.Performance of Programs8

5.Quality AND REGULATORY MATTERS10

6.Conforming batches, NON-CONFORMING BATCHES, DEMONSTRATION BATCHES and engineering BATCHES11

7.Delivery, TITLE AND RISK13

8.Price and Payment13

9.Liability15

10.Intellectual Property18

11.Intellectual Property Indemnity19

12.Confidentiality20

13.Change21

14.DELAY, Cancellation, Termination AND CONSEQUENCES22

15.Force Majeure25

16.Dispute Resolution25

17.Audit26

18.Notices26

19.Export Controls, MODERN SLAVERY AND CORRUPTION27

20.Assignment AND SUB-CONTRACTING28

21.General28

22.Governing Law29

Schedule 1Charges30

Schedule 2Addresses for Notice33

Signature Page34

 

 

FDB Global MSA December 2017

THIS AGREEMENT is made on the date set out above.

BETWEEN

	
(1)
	
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED incorporated and registered in England and Wales with company number 05803359 whose registered office is at Belasis Avenue, Billingham, TS23 1LH, England (“FDBK”); 

	
(2)
	
FUJIFILM DIOSYNTH BIOTECHNOLOGIES TEXAS, LLC incorporated and registered in Texas whose principal place of business is at 100 Discovery Drive, Suite 200 College Station, Texas 77845 United States of America (“FDBT”);

	
(3)
	
FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A., INC incorporated and registered in Delaware whose principal place of business is at 101 J Morris Commons Lane, Morrisville, North Carolina 27560, United States of America (“FDBU”); and

	
(4)
	
AEGLEA BIOTHERAPEUTICS, INC. incorporated and registered in Delaware whose principal place of business is at 901 S. Mopac Expressway, Barton Oaks Plaza One, Suite 250, Austin, TX   78746 (the “Customer”).

BACKGROUND

	
(A)
	
Fujifilm (as defined below) is a biopharmaceutical contract development and manufacturing organization. The Customer wishes to appoint Fujifilm to carry out development and manufacturing services in relation to certain of the Customer’s products.

	
(B)
	
Fujifilm and the Customer have agreed to work together on the terms and conditions contained in this Agreement.

AGREED TERMS

	
1.
	
Definitions and Interpretation

	
1.1
	
In this Agreement the following words have the following meanings unless inconsistent with the context:

		
	
“Affiliate”
	
in respect of any party, any company from time to time directly or indirectly Controlling, Controlled by or under common Control with that party;

	
“Ancillary Services”
	
has the meaning given to it in Schedule 1 (Charges);

	
“Applicable Laws”
	
applicable law, rules, regulations and binding guidance which applies in the jurisdiction in which the Program is being performed;

1

 

 

FDB Global MSA December 2017

		
	
“Background IP”
	
all Intellectual Property Rights controlled, owned or jointly owned by any party (or a third party on its behalf) prior to the Effective Date or developed independently from the Program. Fujifilm’s proprietary manufacturing, expression or purification technologies, including:

(a)an expression system within the scope of international patent application PCT/GB2007/000351 (the “pAVEwayTM Expression System”);

(b)expression technology within the scope of international patent application PCT/GB2014/000165 (the “ApolloTM Expression Technology”); and

(c)Fujifilm’s proprietary alcohol oxidase yeast Pichia pastoris expression system (the “Yeast Expression System”), 

(collectively, “Fujifilm Expression Technology”) is Fujifilm’s Background IP;

	
“Batch”
	
a quantity of Product that is produced from a run of the Process;

	
“Batch Cancellation Fee”
	
the Batch Cancellation Fee described in Schedule 1;

	
“Business Day”
	
(a)in relation to notices given under this Agreement rather than a specific Scope of Work a day other than a Saturday, Sunday or public holiday in England or the US; and

(b)in relation to notices given under a specific Scope of Work a day other than a Saturday, Sunday or public holiday in England if FDBK is a contracting party or the US if FDBT or FDBU is a contracting party;

	
“cGMP”
	
Current Good Manufacturing Practice as defined in (i) the Federal Register volume 66 No 186 and those sections applicable within the FDA Regulations 21 CFR Part 210, 211, 600, 601 and 610 and (ii) the rules governing medicinal products in the European Union. Volume 4 – Guidelines for good manufacturing practices for medicinal products for human and veterinary use, as applicable to the Program and ICHQ7;

	
“cGMP Batch”
	
a Batch identified in a Scope of Work which is intended to be manufactured during a Manufacturing Stage and subject to Disposition in each case in accordance with cGMP; 

	
“Change”
	
has the meaning given to it in clause 13;

 

	
“Charges”
	
has the meaning set out in clause 8.2;

	
“Commercially Reasonable Efforts”
	
with respect to the activities pursuant to a Program, the reasonable efforts and resources used by a reputable biopharmaceutical contract manufacturing organization for drug substances of similar nature, complexity and developmental stage in the same or similar circumstances;

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“Confidential Information”
	
the fact and terms of this Agreement and any Scope of Work, and all information (in whatever form) in respect of the business of each of the parties and each of its Affiliates including any ideas; technologies; business methods; finance; prices, business, financial, marketing or development plans; products or services, know-how or other matters connected with products or services manufactured and/or marketed; customer  lists or details; computer systems and software; which is (in each case) provided or obtained 

by one party to or for the other; notwithstanding anything to the contrary herein;

  (a) Results, information regarding Materials, and Customer’s business, scientific, research, and development plans; and 

(b) for the purposes of Clause 12, Customer Foreground IP; 

shall be deemed solely Customer’s Confidential Information, and with respect to which, Customer shall be the Disclosing Party and Fujifilm the Receiving Party; 

	
“Conforming Batch”
	
a cGMP Batch which has been produced in accordance with cGMP and which meets the Product Specification;

	
“Consumable”
	
a consumable item used or intended for use in a Program, including PEG, reagents (including analytical reagents), raw materials, packaging components, chromatography resins, filters, filtration membranes, media, buffer bags, refold bags, tubing, hoses, disposable analytical test kits, in-process measurement probes, columns (including analytical columns) and disposable containers; 

	
“Control”
	
(a)any power (whether directly or indirectly and whether by the ownership of share capital, the possession of voting power, contract or otherwise) to appoint and/or remove all or such of the members of the board or other governing body of a body corporate as are able to cast the majority of the votes capable of being cast by members of that board or body on all, or substantially all, matters, or otherwise to control or have the power to control the policies and affairs of that body corporate; or

(b)the holding and/or possession of the beneficial interest in and/or the ability to exercise the voting rights applicable to shares or other securities in any person (whether directly or indirectly) which confer in aggregate on the holders thereto 50% or more of the total voting rights exercisable at general meetings of that body corporate on all, or substantially all, matters, 

and “Controlled” and “Controlling” shall be construed accordingly;

	
“Customer Foreground IP”
	
all Foreground IP other than Fujifilm Foreground IP;

	
“Delay”
	
has the meaning given to it in clause 14.1.1;

	
“Demonstration Batch”
	
a Batch which is manufactured in a noncGMP R&D facility for demonstration purposes and which is not intended for human use;

	
“Deviation”
	
a cGMP deviation as detailed in the Quality Agreement;

	
“Disposition”
	
the Stage during which (i) the Product is tested for compliance versus the Product Specification; (ii) all production instruction and analytical records relating to cGMP manufacture of each cGMP Batch prepared by Fujifilm are reviewed; and (iii) a Fujifilm recommendation for Product release or reject is made; in each case as applicable;

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“Drug Product”
	
the final dosage form of product which contains Product in association with other active or inactive ingredients; 

	
“Effective Date”
	
the date of last signature by all parties to this Agreement;

	
“Engineering Batch”
	
a Batch that is manufactured in a cGMP Facility at scale using the Process  including draft batch records but which is not intended for human use;

	
“Facility”
	
any of Fujifilm’s manufacturing facilities in which a Program will be performed; 

	
“Force Majeure Event”
	
any event or circumstances outside the reasonable control of a party affecting its ability to perform any of its obligations under this Agreement including act of God, fire, flood, severe weather, epidemic or pandemic, war, revolution, acts of terrorism, riot or civil commotion, acts of government, trade embargo, labor disputes (excluding labor disputes involving the party in question), interruption of utility service, restraints or delays affecting shipping or carriers, inability or delay in obtaining supplies of adequate or suitable materials, breakdown or failure in equipment or machinery, cyber-attack, currency restrictions, and illness affecting a material number of the Program team, but shall not include the failure of Drug Product in clinical trials or failure of Drug Product to gain regulatory approval;

	
“Foreground IP”
	
all Intellectual Property Rights that arise or are obtained or developed by or on behalf of any party in the course of the performance of a Program;

	
“Fujifilm”
	
FDBK, FDBT and/or FDBU as the context requires in accordance with clause 1.3;

	
“Fujifilm Foreground IP”
	
all Foreground IP that (i) can be generally applied to the production of biologics other than the Product, and (ii) are not specific to or do not require the use of any of Customer’s Confidential Information;

	
“Fujifilm Services”
	
the research and development services to be provided by Fujifilm for the Customer during a Program as the same are described in the relevant Scope of Work excluding the Ancillary Services;

	
 
	
 

	
“Indemnify”
	
on demand to indemnify and keep indemnified, and hold harmless, the party to be indemnified on an after tax basis;

	
“Intellectual Property Right”
	
any current and future intellectual property rights and interests including patents, utility models, designs, design rights, copyright (including rights in software), decryption rights, database rights, trade marks, rights pursuant to passing off, service marks, business and trade names, domain names, know-how, results, data, databases, formulations, compounds, rights in biological or chemical materials, rights under data exclusivity laws, rights under unfair competition laws,  topography rights, inventions, rights in confidential information (including technical and commercial trade secrets); supplementary protection certificates and image rights, and rights of a similar or corresponding character in any part of the world, in each case whether registered or not and including any application for registration and renewals or extensions of such rights in any country in the world and whether subsisting now or in the future;

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“Latent Defect”
	
a defect in a Batch that Sponsor can demonstrate was present at the time of Disposition but was discovered after Disposition (but within the time frame set forth in Section 6) that renders the Batch as Non-Conforming 

Batch.  Inherent stability or instability of a Product shall never give rise to a Latent Defect.  Furthermore, defects caused by Customer’s handling, transportation or storage of the Product shall never give rise to a Latent Defect.

	
“Liabilities”
	
any (i) liabilities whether in contract, tort (including negligence) or otherwise; (ii) losses, costs (including internal costs/overheads), damages, fines or expenses, including reasonable legal fees; and (iii) claim, demand, proceeding, action or cause of action; in each case howsoever arising. “Liability” shall be construed accordingly;

	
“Manufacturing Stage”
	
a Stage of a Program during which production, testing and Disposition (if applicable) of Engineering Batches or cGMP Batches are intended to take place, including pre and post manufacturing activities; Facility change–over, setup, and cleaning before, between and after Batch manufacturing;

	
“Modifications”
	
a modification to a Facility; or equipment (including Process specific qualification and installation of existing equipment), required in order to perform a Process and detailed in the applicable Scope of Work; 

	
“Non-Conforming Batch”
	
a cGMP Batch which has not been produced in accordance with cGMP and/or does not meet the Product Specification;

	
“Non-Manufacturing Stage”
	
a Stage of a Program, which is not a Manufacturing Stage, during which the non-manufacturing activities described in the relevant SoW are  undertaken including the production and testing of Demonstration Batches;

	
“Process”
	
a particular process used, or to be used, for manufacture of a Product;

	
“Process-Specific Consumable”
	
a Consumable which is required to operate the Process and which is specific to the Process or a Consumable which is required in such large volumes as would not be possible for Fujifilm to consume during other manufactures and/or within the shelf life of such Consumable;

	
“Process-Specific Equipment”
	
an item of equipment which is required by Fujifilm to operate the Process and which is specific to the Process in addition to that equipment which Fujifilm uses in its Facilities as at the SoW Effective Date (which existing equipment is not already dedicated to other customer(s) of Fujifilm);

	
“Product”
	
the particular product or substance (compound or molecule) created during and as a result of performing the Process. The name of relevant Product is identified in the applicable Scope of Work;

	
“Product Specification”
	
the Product specification which is documented in a QA Document;

	
“Program”
	
a program of work as set out in the applicable Scope of Work (or more than one Scope of Work, as the case may be) to be carried out by Fujifilm in accordance with the terms of this Agreement;

	
“Program Cancellation Fee”
	
the Program Cancellation Fee described in Schedule 1;

	
“Program Manager”
	
the Program manager appointed by each of Fujifilm and the Customer under the applicable SoW;

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FDB Global MSA December 2017

		
	
“Program Plan”
	
the Program plan controlled by Fujifilm’s Program Manager and communicated to the Customer from time to time;

	
“Quality Agreement”
	
the document agreed by the parties which sets out the mutually agreed quality standards applicable for any cGMP or pre-cGMP activity under the Program;

	
“QA Documents”
	
the Quality Agreement and the documents produced and approved in accordance with the Quality Agreement;

	
"Results”

 

“Regulatory Authority” 
	
all data and tangible property obtained or generated by Fujifilm in the course of providing the Programs or arising out of the use of Customer's Confidential Information;

the U.S. Food and Drug Administration, the European Medicines Agency, the Medicines & Healthcare products Regulatory Agency, and any successor to any such entities;

	
“Scope of Work” or “SoW”
	
the document setting out the detail of the work to be undertaken by Fujifilm for the Customer;

	
“SoW Effective Date”
	
for each Scope of Work, the date that the Scope of Work is fully signed by all relevant parties;

	
“Special Waste”
	
waste or effluent which requires special handling including waste or effluent which is required to be collected in a special container (for example by tanker) for external disposal or which requires incineration;

	
“Stage”
	
a stage of the Program as described in the SoW;

	
“Subcontracted Work”
	
work subcontracted by Fujifilm under clause 20.3 but excluding any work subcontracted between FDBK, FBDT and/or FDBU;

	
“Target Specifications”
	
With respect to a Demonstration Batch or Engineering Batch, the Product Specifications for safety with regards to bioburden and endotoxin and identity of the Product as mutually agreed by the parties and set forth in the batch records.

	
“Tax”
	
value added tax, sales tax or any other similar type of turnover tax; and

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FDB Global MSA December 2017

		
	
“Unforeseen Technical Factor”
	
either (i) a change to Applicable Laws which comes into effect after the applicable SoW Effective Date or (ii) an event or circumstance (not caused by a breach by Fujifilm of clause 4.1) which:

(a)adversely affects the development of the Process; or

(b)adversely affects, or is likely to adversely affect, production of Product by the Process when conducted in accordance with Fujifilm’s standard operating procedures or methods, and within the declared constraints of the Facility; or

(c)is likely to have an adverse effect on any customer Product Licence (being the licence authorising marketing of a medicinal product granted by a Regulatory Authority (also known as a “Marketing Authorisation” in Europe)) or Manufacturing Licence (being the licence to manufacture biotechnology-derived drug substances issued to Fujifilm by the applicable Regulatory 

Authority) as a result of the Product being introduced into the Facility,

which in each case was not known by Fujifilm and could not reasonably have been known by Fujifilm as at the applicable SoW Effective Date.

	
1.2
	
In this Agreement (except where the context otherwise requires) any words following the terms “including”, “include”, “for example” or any similar expression are by way of illustration and emphasis only and shall not limit the generality or extent of any other words or expressions.

	
1.3
	
Each Scope of Work will be entered into by FBDK, FBDT or FDBU or a combination of FDBK, FDBT and/or FDBU and, subject to clause 18.3, each reference to Fujifilm or a “party” in this Agreement shall apply only to such of FBDK, FBDT and/or FDBU as is carrying out the Program under the relevant Scope of Work. Whichever of FBDK, FBDT and/or FDBU has entered into the Scope of Work in respect of that Program shall be fully and solely responsible for the obligations and liabilities of that party under the Scope of Work.

	
1.4
	
Insofar as this Agreement obliges any party to this Agreement to negotiate, take action or to do something, that party shall conduct such negotiations, take such action or do such thing in good faith and, in the case of Fujifilm, using Commercially Reasonable Efforts to achieve the result contemplated in this Agreement. There shall be a general obligation on the parties to act in good faith in relation to the matters contemplated in this Agreement.

	
1.5
	
In the case of conflict or ambiguity between terms of the main body of this Agreement, any Schedule to this Agreement or any other terms in any Scope of Work, the order of priority shall be as follows: (i) the main body of the Agreement; (ii) the Schedules to the Agreement; and (iii) the main body of the Scope of Work unless a Scope of Work specifically varies a provision of the Agreement or a Schedule to the Agreement by reference to the provision it is amending in which case the Scope of Work shall take precedence in that instance.

	
1.6
	
In the case of conflict or ambiguity between the terms of this Agreement or any specific Scope of Work and the terms of the QA Documents, the terms of the QA Documents shall prevail solely in relation to cGMP quality matters subject to clause 9.9.

	
1.7
	
Where a defined term is used in clause 9 (Liability) it shall retain its meaning even when the entire word that is a defined term is in capitals. 

	
2.
	
Appointment of Fujifilm

	
2.1
	
This Agreement establishes the general terms and conditions applicable to Fujifilm’s performance of each Program for the Customer and is structured so that a separate, numbered, Scope of Work (or in some cases multiple Scope of Works) shall be entered into by the parties for the provision of each Program. 

	
2.2
	
The provisions of this Agreement shall apply to each Scope of Work and no Scope of Work shall be effective or binding on any party until it has been signed by an authorized representative of each contracting party.

	
2.3
	
Nothing in this Agreement or any Scope of Work shall oblige any party to enter into any Scope of Work and each Scope of Work constitutes a separate contract. 

	
3.
	
Term 

	
3.1
	
This Agreement shall come into force on the Effective Date and shall continue until terminated by a party in accordance with the terms of this Agreement.

	
3.2
	
A party may terminate this Agreement upon giving 6 (six) months’ written notice to the others, provided that there are no uncompleted Programs existing at the date such notice is given.

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FDB Global MSA December 2017

	
3.3
	
Each Scope of Work will take effect from the SoW Effective Date and shall continue until the earlier of:

	
 
	
3.3.1
	
the date specified in the Scope of Work, or if no such date is specified, the date the Program, or part of the Program referred to in the Scope of Work is completed; or 

	
 
	
3.3.2
	
termination of this Agreement or the relevant Scope of Work in accordance with the terms of this Agreement.

	
4.
	
Performance of Programs

	
4.1
	
Fujifilm shall carry out each Program: 

	
 
	
4.1.1
	
in accordance with the terms of this Agreement and any Scope of Work;

	
 
	
4.1.2
	
in accordance with all Applicable Laws;

	
 
	
4.1.3
	
in accordance with the Quality Agreement and cGMP (in both cases when applicable); 

	
 
	
4.1.4
	
in compliance with the Process when a Process has been mutually agreed by the parties;

	
 
	
4.1.5
	
in a professional and workmanlike manner, in accordance with industry standards; and

	
 
	
4.1.6
	
using Commercially Reasonable Efforts. 

	
4.2
	
The parties agree that it shall not be considered a breach of this Agreement by Fujifilm if an objective of a Program is not achieved provided that Fujifilm has complied with its obligations set out in clause 4.1. Notwithstanding any contrary provisions in this Agreement, the parties acknowledge and agree that the services to be performed during the Programs are by their nature developmental and Fujifilm cannot (and consequently does not) guarantee to the Customer the achievement of a successful outcome for a Program, production of Conforming Batches or production of a specified volume of Product. 

	
4.3
	
Upon request by the Customer, the parties agree to negotiate in good faith a commercial supply agreement with each other for the Product. 

 

	
4.4
	
Each Scope of Work contains key assumptions on which Fujifilm’s ability to perform the Program depends. If the key assumptions set out in the Scope of Work prove to be incorrect or actual circumstances differ from the key assumptions (including if such key assumptions cannot be met at such time as Fujifilm reasonably requires to enable it to perform its obligations) then the parties shall negotiate in good faith and agree a reasonable Change to account for the change in key assumptions. If the parties are unable to agree such Change and the dispute resolution process set out in clause 16 has been unsuccessfully exhausted Fujifilm may terminate the relevant SoW(s) and such termination shall be deemed to be for the Customer’s convenience and clause 14.3 shall apply.

	
4.5
	
The Customer shall:

	
 
	
4.5.1
	
meet all its obligations and responsibilities under this Agreement, any Scopes of Work and the Quality Agreement;

	
 
	
4.5.2
	
comply with Applicable Laws; and

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FDB Global MSA December 2017

	
 
	
4.5.3
	
promptly provide all reasonable assistance, information, and advice and do all acts which Fujifilm may reasonably request to enable Fujifilm to comply with its obligations and responsibilities under this Agreement, any Scope of Work and the Quality Agreement. 

	
4.6
	
Representations and Warranties:

	
 
	
4.6.1
	
Each party represents and warrants to the other party that:

(a) neither it nor any of its employees, or any agents are currently excluded, debarred, or otherwise made ineligible to participate in any federal health care program defined in 42 U.S.C. § 1320a-7b(f) (the "Federal Healthcare Programs"), any other government procurement or non-procurement program, or is subject to any penalty or exclusion imposed by the Food and Drug Administration. Fujifilm further represents and warrants that to its knowledge none of its subcontractors (including their employees) are currently excluded, debarred, or otherwise made ineligible to participate in any Federal Healthcare Programs, any other government procurement or non-procurement program, or is subject to any penalty or exclusion imposed by the Food and Drug Administration. Each party further represents and warrants to the other party that, to its knowledge, neither it nor any of its employees, or any agents or subcontractors (including their employees) (i) has been convicted of a criminal offense related to the provision of health care items or services but has not yet been excluded, debarred, or otherwise declared to be either ineligible to participate in the Federal Healthcare Programs or subject to any penalty or exclusion imposed by the Food and Drug Administration, or (ii) has been notified by a government agency of an investigation or other formal proceeding that may result in any criminal, civil, or administrative penalty involving the Federal Healthcare Programs or any exclusion or penalty imposed by the Food and Drug Administration.  The parties further agree that this obligation shall continue throughout the term of this Agreement, that an affected party shall notify the other party immediately of any change in these representations and warranties of which it becomes aware and the other party shall have the immediate right to terminate this Agreement upon receipt of any such notice of change; and

(b)it has all requisite corporate power and authority to enter into and perform all of its obligations under this Agreement. The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action in respect thereof on the part of such party. Neither the execution and delivery of this Agreement nor the performance of the transactions contemplated hereby, nor compliance by Fujifilm with the provisions hereof, shall conflict with any obligations or agreements of such party to any person, contractual or otherwise

	
 
	
4.6.2
	
Customer represents and warrants to Fujifilm that it has legal title and/or a valid license to the cell line, raw material, expression systems, process patents and the Product necessary to conduct the Program and that to Customer’s knowledge, Fujifilm’s performance of the Program will not infringe any Intellectual Property Rights or other rights of third parties.

	
 
	
4.6.3
	
Fujifilm represents and warrants to the Customer that:

(a) All Product shall be manufactured in the Facility, unless mutually agreed otherwise;

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FDB Global MSA December 2017

(b)unless delivery of a Non-Conforming Batch is requested by Customer, Fujifilm shall not deliver a Non-Conforming Batch to Customer;

(c)Fujifilm has, and will remain in material compliance with, all permits, licenses and other authorizations (the "Permits") which are required under Applicable Laws for the manufacture, testing, storage, and/or handling of Product;

(d)to Fujifilm's knowledge, Fujifilm's use of Fujifilm’s Background IP in the manufacture of Product in the performance of this Agreement will not infringe any Intellectual Property Rights or other rights of third parties; and

(e)upon payment pursuant to clause 8, title to all Product provided to the Customer hereunder shall pass to Customer as provided herein, free and clear of any security interest, lien, or other encumbrance.

	
5.
	
Quality AND REGULATORY MATTERS

	
5.1
	
Quality Agreement

	
 
	
5.1.1
	
As soon as reasonably practicable following the Effective Date the parties shall execute the Quality Agreement (unless the Quality Agreement has already been executed prior to the Effective Date). 

	
 
	
5.1.2
	
The Customer acknowledges that Fujifilm shall not commence any cGMP or pre-cGMP activity until the Quality Agreement is executed by both parties.

	
5.2
	
Regulatory Assistance 

	
 
	
5.2.1
	
The Customer shall provide Fujifilm with a copy of the Customer’s Chemistry, Manufacturing and Controls section of any submission to a Regulatory Authority supporting the Customer’s regulatory filing activities for the applicable Drug Product or Process to the extent relating to or impacting Fujifilm (“CMC Section”) for Fujifilm’s review and comment before submission to such Regulatory Authority. Fujifilm shall provide any comments on the CMC Section to the Customer within such ten (10) day period, which the Customer shall consider in good faith before submission; if the Customer receives no such comments within such period, the CMC Section shall be deemed approved by Fujifilm.

	
 
	
5.2.2
	
During each Program the Customer may request assistance from Fujifilm in respect of the CMC Section, subject to payment by the Customer of a reasonable commercial rate for such assistance and Fujifilm’s reasonable expenses. However, no advice or assistance given by Fujifilm shall be deemed to be or construed as a guarantee that a Drug Product will receive regulatory approval. 

*Confidential Treatment Requested.

 
Fujifilm shall use Commercially Reasonable Efforts to assist the Customer, which may be at Customer’s cost, in connection with obtaining regulatory approvals in the United States and Europe with respect to the Product.  Regulatory approvals in subsequent jurisdictions will be subject to a Change.  Fujifilm will promptly [*] provide one electronic (PDF) copy of any documents which may be reasonably required by the Customer in support of its regulatory filing activities. If the Customer requires copies of the laboratory notebooks, provision of these will be subject to discussion and agreement by the parties and agreement of an additional fee associated with copying.

	
 
	
5.2.4
	
The Customer shall have the right and responsibility for determining regulatory strategy, decisions and actions relating to each Program and any Product and/or Drug Product subject to clause 5.2.5 and provided that Fujifilm shall have the right and 

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FDB Global MSA December 2017

	
 
		
responsibility for determining regulatory strategy, decisions and actions to the extent relating to:

	
 
	
(a)
	
the Facility (including in particular utilities and equipment);

	
 
	
(b)
	
Fujifilm’s quality systems, policies and internal procedures;

	
 
	
(c)
	
any requirement imposed on Fujifilm by a Regulatory Authority; or

	
 
	
(d)
	
any other commitments made by Fujifilm prior to the relevant SoW Effective Date of the applicable Program, 

(each a “Fujifilm Regulatory Responsibility”). 

	
 
	
5.2.5
	
The Customer acknowledges that Fujifilm Quality Assurance team reserves the right to Disposition Product to Customer in accordance with the Quality Agreement.  Customer has the responsibility to determine whether to release cGMP Product for use in clinical trials.

	
 
	
5.2.6
	
The Customer shall not make any change to its regulatory filings, including its Investigational New Drug application, which may have a direct impact on any Fujifilm Regulatory Responsibility without prior written approval of Fujifilm, such approval not to be unreasonably withheld.

	
 
	
5.2.7
	
 Fujifilm will allow representatives of any Regulatory Authority with jurisdiction over the manufacture, marketing, distribution and sale of the Product to tour and inspect the Facility, and will cooperate with such representatives in every reasonable manner. 

	
6.
	
Conforming batches, NON-CONFORMING BATCHES, DEMONSTRATION BATCHES and engineering BATCHES

	
6.1
	
Neither a Demonstration Batch nor an Engineering Batch can ever be a Non-Conforming Batch and the Customer shall pay for every Demonstration Batch and Engineering Batch completed [*]. Product produced pursuant to a Demonstration Batch or an Engineering Batch is not suitable for human consumption or use or clinical trials. 

	
6.2
	
Each cGMP Batch will be determined to be a Conforming Batch or a Non-Conforming Batch.

	
6.3
	
If during a Manufacturing Stage relating to a cGMP Batch Fujifilm discovers any significant Deviation it will be handled in accordance with the Quality Agreement. The Customer agrees that only Deviations, alone or in combination, which are determined or reasonably considered to affect Product quality will cause a cGMP Batch to be classified as a Non-Conforming Batch. 

	
6.4
	
In respect of Conforming Batches, Fujifilm will complete Disposition, issue a certificate of analysis and a cGMP compliant statement, and provide additional documentation as agreed upon in the Quality Agreement. The provisions of clauses 6.5 to 6.7 shall apply to Non-Conforming Batches only.

*Confidential Treatment Requested.

 
If a Batch is a Non-Conforming Batch and the cause of that Batch being a Non-Conforming Batch is not a failure by Fujifilm to comply with clause 4.1, then the Customer shall pay the Charges relating to the Non-Conforming Batch in full and the relevant Manufacturing Stage, Disposition and all related and ancillary activities shall be deemed to have been completed under the Scope of Work. Further work in relation to the Non-Conforming Batch, such as analysis of the Batch, shall be promptly performed and reported. If requested by Customer, manufacture of a replacement cGMP Batch shall be carried out at a time and price to be agreed in writing by the parties in a Change.
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FDB Global MSA December 2017

	
6.6
	
Except as set forth in Section 6.6.3, if a Batch is a Non-Conforming Batch and the cause of the Batch being a Non-Conforming Batch is a failure by Fujifilm to comply with clause 4.1 , then either:

	
 
	
6.6.1
	
if the Customer requests delivery of the Non-Conforming Batch, the parties shall agree in writing (in a Change) on fair consideration payable under the Scope of Work in respect of that Batch, and Fujifilm’s obligation in relation to that Batch shall be deemed to be completed when such Change is signed and that Batch is delivered; or

if the Customer does not request delivery of the Non-Conforming Batch, at the Customer’s option, Fujifilm shall use  Commercially Reasonable Efforts to manufacture a replacement cGMP Batch (“Replacement Batch”) as soon as is reasonably practicable at no additional cost to Customer (though Customer shall be obliged to pay for all Charges in respect of the original Non-Conforming Batch in accordance with the SoW), plus the Charges for the Ancillary Services provided in relation to the Replacement Batch[*]

*Confidential Treatment Requested.

 

	
 
	
6.6.3
	
In the event the first Batch of a Program is a cGMP Batch not preceded by an Engineering Batch, Fujifilm shall be responsible under this Section 6.6 for the first such cGMP Batch being a Non-Conforming Batch only if the non-conformance is caused by Fujifilm’s gross negligence or willful misconduct.  

	
6.7
	
In the event of a Latent Defect, Customer shall notify Fujifilm of such Latent Defect within the earlier of (a) [*] after discovery of the Latent Defect and (b) [*] after Disposition.  If the cause of the Latent Defect is a failure by Fujifilm to comply with clause 4.1, Section 6.6 shall apply.

	
6.8
	
In case of any disagreement between the parties as to whether a cGMP Batch is a Non-Conforming Batch and the cause of a Non-Conforming Batch, the respective quality assurance representatives of the parties will attempt in good faith to resolve any such disagreement and the Customer and Fujifilm will follow their respective standard operating procedures to determine whether the Batch is a Non-Conforming Batch and if a Non-Conforming Batch, whether it was caused by Fujifilm’s failure to follow Section 4.1.  In the event such activities do not resolve the issue, the Parties shall follow the dispute resolution process set forth in the Quality Agreement.

	
6.9
	
If the Customer requires delivery of a Non-Conforming Batch it must make such request to Fujifilm in writing within [*] of being informed that the Batch is a Non-Conforming Batch. Fujifilm agrees to deliver a Non-Conforming Batch to the Customer on the express condition that it (i)  will not be used for human or clinical trials; (ii) will be labeled as “Not for Human Use”; and (iii) is subject to the Customer’s indemnity given under clause 9.5.

	
7.
	
Delivery, TITLE AND RISK

	
7.1
	
Delivery by Fujifilm to the Customer of any material in connection with the Program including any quantity of Product manufactured during the Program, any Process-Specific Equipment and/or Process-Specific Consumables and return of any samples, cell lines and other materials supplied by the Customer (“Materials”) will be made Ex Works the Facility (Incoterms 2010) and clauses 7.2 to 7.5 shall apply to such Materials. Fujifilm shall package the relevant Material ready for shipment in accordance with the Customer’s reasonable instructions. Except to the extent set forth in Section 3.4 of Schedule 1, Fujifilm shall use Materials only for the purpose of performing the Programs and shall not subject such Materials to any analysis or use inconsistent with the Programs.  Except to the extent set forth in Section 3.4 of Schedule 1, in no event shall Fujifilm use Materials for its own benefit or in connection with the performance of services for third parties.

	
7.2
	
Delivery of Materials will be deemed to be completed at the time at which Fujifilm makes the Materials available for collection by the Customer (which is the point of delivery as set forth in Ex Works (Incoterms 2010)).

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If the Customer fails to collect Materials that have been deemed to be delivered under clause 7.2, Fujifilm shall provide notice to Customer and if Customer does not arrange for collection within [*] Fujifilm may, at its discretion, either arrange for delivery of the Materials to the Customer at the Customer’s risk and expense or destroy those Materials. 

*Confidential Treatment Requested.

 

	
7.4
	
Risk in the Material shall pass to the Customer on the completion of actual delivery.  

	
7.5
	
Title to the Product shall pass to the Customer on delivery. 

	
7.6
	
Title to the Process-Specific Equipment and/or Process-Specific Consumables purchased by the Customer in accordance with Schedule 1 shall not pass to the Customer until Fujifilm has received payment in full (in cash or cleared funds) for such items in accordance with paragraph 3.1 of Schedule 1.

	
7.7
	
Delivery of any Materials which the Customer is required to supply to Fujifilm pursuant to the SoW shall be delivered to Fujifilm DDP, the Facility (Incoterms 2010). Title to Materials provided by Customer shall remain vested in Customer. Fujifilm shall at all times use reasonable efforts to keep such Materials secure and safe from loss or damage.  Subject to the limitations of liability set forth below, Fujifilm shall be liable for loss or damage to such Materials resulting from its gross negligence or intentional misconduct.  Customer grants Fujifilm the right to use such Materials solely to the extent required to perform the any Program.     

	
8.
	
Price and Payment

	
8.1
	
Under this Agreement, and the relevant Scope of Work, the Customer appoints Fujifilm to carry out services concerning the research and development, testing, manufacture and Disposition of the Product by Fujifilm under a Program. The Charges relate specifically to those services; and are not in consideration of the supply of any material (including Product) which Fujifilm may produce as a consequence of the performance of those services.

	
8.2
	
The Customer shall pay to Fujifilm for each Program:

	
 
	
8.2.1
	
the fees for the Fujifilm Services as set out in the relevant Scope of Work; and

	
 
	
8.2.2
	
the fees for Ancillary Services in accordance with Schedule 1,

together the “Charges”.

	
8.3
	
Fujifilm may invoice the Customer for the Charges in respect of each Program in accordance with the terms set out in the Scope of Work and Schedule 1. Fujifilm shall also use Commercially Reasonable Efforts to invoice the Customer for all taxes due with respect to the Charges, provided that Fujifilm shall be responsible for all taxes relating to its revenue derived under this Agreement.

	
8.4
	
The Customer shall pay all invoiced, undisputed amounts within 30 (thirty) days of receipt of invoice, in full and in cleared funds in the currency specified in the SoW by electronic transfer to the financial institution specified in the relevant invoice. 

	
8.5
	
The Charges are exclusive of any Tax which may apply and which shall be payable by the Customer to Fujifilm at the rate prescribed by law. 

	
8.6
	
If there is a change in the rate of Tax payable or in the Tax treatment of some or all of the services provided by Fujifilm or the Product, a change of law or practice or interpretation of the existing legislation or revised determination by HMRC (Her Majesty’s Revenue and Customs) or the IRS (Internal Revenue Service), or the supply of services by Fujifilm has been incorrectly regarded as Tax exempt, or if the courts rule Tax is chargeable,  then the Customer agrees that Fujifilm shall be entitled, where Tax is imposed on a supply by Fujifilm under or in connection with this Agreement (including the retrospective application of Tax upon services which Fujifilm has already performed and which have previously been invoiced on a Tax exempt basis), to invoice the Customer (in a valid Tax invoice) for a sum equal to the amount of the Tax which 

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becomes due on that supply and any fees and/or interest which HMRC and/or the IRS levies on Fujifilm in relation to the outstanding sums and/or non-payment. The Customer shall pay those invoices in accordance with clause 8.4.

	
8.7
	
The Customer shall:

	
 
	
8.7.1
	
be responsible for the collection, remittance and payment of any or all taxes, charges, levies, assessments and other fees of any kind imposed by governmental or other authority in respect of the purchase, importation, exportation, sale or other distribution of any materials delivered to it by Fujifilm in connection with the Program; and 

	
 
	
8.7.2
	
make all payments under this Agreement without withholding or deduction of, or in respect of, any tax unless required by law. If any such withholding or deduction is required, the Customer shall, when making the payment to which the withholding or deduction relates, pay to Fujifilm such additional amount as will ensure that Fujifilm receives the same total amount that it would have received if no such withholding or deduction had been required.

	
8.8
	
Without prejudice to any other right or remedy that it may have, if the Customer fails to pay any invoiced, undisputed amounts to Fujifilm on the due date for payment:

the Customer shall pay interest on the overdue amount at the rate of [*] per month. Such interest shall be payable in respect of the period from the due date until actual payment of the overdue amount (whether before or after judgment) in accordance with clause 8.4; and

*Confidential Treatment Requested.

 

	
 
	
8.8.2
	
(except where the Customer has complied with its obligations in clause 8.9 below) Fujifilm may notify the Customer that if it does not pay Fujifilm will suspend work on the Program in respect of which payment is overdue, and if payment is not made within [*] of such notice, Fujifilm may suspend such work until payment has been made in full.

	
8.9
	
If the Customer disputes the payment of any Charges or a part of them, the Customer shall:

	
 
	
8.9.1
	
notify Fujifilm of the disputed amount within [*] of its receipt of the invoice in which such disputed amount is included giving reasonable details of the dispute; and

	
 
	
8.9.2
	
pay the amount of Charges not in dispute in accordance with clause 8.4,

and the dispute shall be dealt with under the dispute resolution process set out in clause 16.

	
8.10
	
If the Customer fails to pay any invoiced amount which is not the subject of a bona fide dispute under clause 8.9 when the same is due in accordance with clause 8.4 then Fujifilm may elect, at its discretion and [*], to treat such non-payment as a material breach of either the relevant SoWs under clause 14.5.1 or a material breach of this Agreement under clause 14.2.1. 

	
8.11
	
A party shall not be entitled to withhold, set off or reduce payment of any amounts payable under this Agreement by any amounts which it claims are owed to it by another party under this Agreement or any other agreement. 

	
9.
	
Liability

	
9.1
	
The parties agree that:

	
 
	
9.1.1
	
the potential extent of Liability arising from the Programs and the Product are each better known to the Customer than to Fujifilm; 

	
 
	
9.1.2
	
the potential extent of such Liability is disproportionate to the amounts which Fujifilm can reasonably charge for its performance of the Programs;

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9.1.3
	
the Customer is better able to, and should, insure against any Liabilities the Customer might suffer, 

and that consequently Fujifilm should restrict its Liability as set out in this clause 9 and the Customer should Indemnify Fujifilm in accordance with clauses 9.3, 9.4, 9.5.3, and 9.6.3 and the parties agree that clause 9.2 does not limit or exclude the Customer’s Liability to Fujifilm under those indemnities.

	
9.2
	
SAVE THAT NOTHING IN THIS AGREEMENT LIMITS OR EXCLUDES THE LIABILITY OF ANY PARTY TO THE OTHER FOR ANY LIABILITY THAT IS NOT PERMITTED TO BE LIMITED OR EXCLUDED BY LAW:

	
 
	
9.2.1
	
Except WITH REGARD TO breaches OF Clauses 10 or 12, in no event shall a Party be liable to ANy other Party for any special, indirect, incidental, punitive or consequential damages in any way related to this Agreement or such Party’s performance of its obligations hereunder. 

[*] FUJIFILM’S TOTAL LIABILITY, WHETHER OR NOT ARISING PURSUANT TO THE INDEMNITY, IN CONTRACT, TORT (INCLUDING NEGLIGENCE OR BREACH OF STATUTORY DUTY), MISREPRESENTATION, RESTITUTION OR OTHERWISE ARISING UNDER THIS AGREEMENT OR A SCOPE OF WORK OR IN CONNECTION WITH THE PERFORMANCE OR CONTEMPLATED PERFORMANCE OF THIS AGREEMENT OR A SCOPE OF WORK SHALL IN ALL CIRCUMSTANCES BE LIMITED AS FOLLOWS:

*Confidential Treatment Requested.

 

	
 
	
(a)
	
IN RESPECT OF ANY LIABILITY ARISING UNDER A SCOPE OF WORK, FUJIFILM’S LIABILITY TO CUSTOMER SHALL BE LIMITED [*]; AND

	
 
	
(b)
	
IN RESPECT OF ANY OTHER LIABILITY RELATING TO THIS AGREEMENT, FUJIFILM’S LIABILITY TO CUSTOMER SHALL BE LIMITED [*].

	
 
	
9.2.3
	
[*]

	
9.3
	
Liability for Product and Drug Product: the Customer shall Indemnify Fujifilm from and against all Liabilities directly related to any third party claim incurred by Fujifilm or its Affiliates arising out of or resulting from the use or resale of the Product or the Drug Product or any other deliverable arising out of the Program; provided, however, that the Customer shall have no obligation to Indemnify Fujifilm from such Liabilities to the extent they arose from the gross negligence or intentional misconduct of Fujifilm or Fujifilm’s material breach of clause 4.6.3(b).

	
9.4
	
Liability for the Process: the Customer shall Indemnify Fujifilm from and against all Liabilities directly related to any third party claim incurred by Fujifilm or its Affiliates arising out of or resulting from the use or operation of the Process (or any part of the Process) except to the extent that Fujifilm is liable under clause 11.1; provided, however, that the Customer shall have no obligation to Indemnify Fujifilm from such Liabilities to the extent they arose from the gross negligence or intentional misconduct of Fujifilm.

	
9.5
	
Liability for Non-Conforming Batches: 

	
 
	
9.5.1
	
THE PROVISIONS OF CLAUSE 6 SHALL APPLY TO NON-CONFORMING BATCHES AND FUJIFILM SHALL HAVE NO LIABILITY IN RESPECT OF NON-CONFORMING BATCHES EXCEPT TO COMPLY WITH CLAUSE 6.6. 

	
 
	
9.5.2
	
FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER (WHETHER AS TO COMPLIANCE WITH CGMP OR OTHERWISE) IN RESPECT OF NON-CONFORMING BATCHES OR THE USE BY THE CUSTOMER OF NON-CONFORMING BATCHES.

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FDB Global MSA December 2017

	
 
	
9.5.3
	
If the Non-Conforming Batch is delivered to the Customer pursuant to clause 6, the Customer shall fully Indemnify Fujifilm from and against all Liabilities directly related to any third party claim incurred by Fujifilm or its Affiliates arising out of or resulting from the use of that Non-Conforming Batch. 

	
 
	
9.5.4
	
The Customer uses any material produced in a Non-Conforming Batch at its own risk and shall undertake such tests as are necessary in order to satisfy itself that such materials are fit for the purposes for which the Customer proposes to use such materials.

	
9.6
	
Liability for Demonstration and Engineering Batches

	
 
	
9.6.1
	
FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER (WHETHER AS TO COMPLIANCE WITH CGMP OR OTHERWISE) IN RESPECT OF THE DEMONSTRATION BATCHES OR ENGINEERING BATCHES OR THE USE BY THE CUSTOMER OF AN ENGINEERING BATCH OR DEMONSTRATION BATCH.

	
 
	
9.6.2
	
FUJIFILM SHALL HAVE NO LIABILITY TO THE CUSTOMER IN CONNECTION WITH DEMONSTRATION BATCHES OR ENGINEERING BATCHES OR THE USE BY THE CUSTOMER OF THE DEMONSTRATION BATCHES OR ENGINEERING BATCHES. 

	
 
	
9.6.3
	
The Customer shall fully Indemnify Fujifilm from and against all Liabilities directly related to any third party claim incurred by Fujifilm or its Affiliates arising out of or resulting from the use of the Demonstration Batches or Engineering Batches.

	
 
	
9.6.4
	
The Customer uses any material produced in a Demonstration Batch or Engineering Batch at its own risk and shall undertake such tests as are necessary in order to satisfy itself that such materials are fit for the purposes for which the Customer proposes to use such materials.

	
9.7
	
Fujifilm shall Indemnify the Customer from and against all Liabilities directly related to any third party claim incurred by the Customer or its Affiliates related to this Agreement to the extent they arose from the gross negligence or intentional misconduct of Fujifilm; provided, however, that Fujifilm shall have no obligation to Indemnify Customer from such Liabilities to the extent they arose from the gross negligence or intentional misconduct of Customer.

	
9.8
	
FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER IN RESPECT OF ANY ADVICE OR ASSISTANCE GIVEN BY FUJIFILM IN CONNECTION WITH THE USE OF THE PRODUCT IN OR AS A DRUG PRODUCT (INCLUDING ADVICE OR ASSISTANCE RELATED TO ANY REGULATORY APPROVAL); AND FUJIFILM SHALL HAVE NO LIABILITY TO THE CUSTOMER IN CONNECTION WITH ANY SUCH ADVICE OR ASSISTANCE.

	
9.9
	
ALL WARRANTIES, CONDITIONS AND OTHER TERMS, EXPRESS (OTHER THAN THOSE SET OUT IN THIS AGREEMENT) OR IMPLIED, STATUTORY, CUSTOMARY OR OTHERWISE WHICH BUT FOR THIS CLAUSE 9 WOULD OR MIGHT SUBSIST IN FAVOR OF THE CUSTOMER, ARE (TO THE FULLEST EXTENT PERMITTED BY LAW) EXCLUDED FROM THIS AGREEMENT INCLUDING, IN PARTICULAR, ANY IMPLIED WARRANTIES RELATING TO MERCHANTABILITY, FITNESS FOR A PARTICULAR USE AND NON-INFRINGEMENT.

	
9.10
	
No claim for Liabilities incurred pursuant to the Quality Agreement may be made under the Quality Agreement by any party. Accordingly, performance of the Quality Agreement shall be deemed to be performance under the SoW to which the Quality Agreement relates and as such any breach of the Quality Agreement shall be deemed to be a breach of the relevant SoW and all Liabilities shall be construed and limited in accordance with this clause 9.

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FDB Global MSA December 2017

	
9.11
	
Each party agrees to take all reasonable steps to mitigate any Liabilities that it may seek to claim from the other under or in connection with this Agreement including pursuant to any Indemnity.

	
9.12
	
If a party is entitled to benefit from an Indemnity (the “Indemnified Party”) from another party (the “Indemnifying Party”) in accordance with this Agreement (an “Indemnity Claim”), the Indemnified Party shall promptly notify the Indemnifying Party in writing of the Indemnity Claim (providing all necessary details) and the Indemnifying Party shall at its own expense conduct all negotiations and any litigation arising in connection with the Indemnity Claim provided always that:

	
 
	
9.12.1
	
the Indemnified Party shall have the right to obtain separate legal counsel at its own expense if it so chooses;

	
 
	
9.12.2
	
the Indemnifying Party shall consult the Indemnified Party on all substantive issues which arise during the conduct of such litigation and negotiations and shall consider the interests of the Indemnified Party in good faith;

	
 
	
9.12.3
	
the Indemnifying Party shall not settle or compromise the Indemnity Claim without the Indemnified Party's prior written consent (not to be unreasonably withheld or delayed) and shall ensure that any settlement or compromise does not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of the Indemnified Party; 

	
 
	
9.12.4
	
the Indemnified Party shall not make any admissions or admit liability in relation to the Indemnity Claim or otherwise settle any Indemnity Claim without the written agreement of the Indemnifying Party; and 

	
 
	
9.12.5
	
the Indemnified Party shall fully cooperate and assist the Indemnifying Party, at the Indemnifying Party’s cost and expense, in relation to the Indemnity Claim (without limiting the extent of the Indemnity).

	
9.13
	
Each party shall maintain in effect appropriate insurance for the term of the Agreement in amounts sufficient to meet its obligations under this Agreement.  Each party shall notify the other parties in writing within thirty (30) days of any notice of cancellation or non-renewal of, or material change in, or claim against, its insurance coverage that could reasonably affect its obligations under this clause 9.13.  Each party shall provide certificates of insurance to the other parties upon reasonable request. Each party’s insurance coverage shall comply with Applicable Laws.

	
10.
	
Intellectual Property 

	
10.1
	
Subject to clause 10.2 no party shall acquire any right, title or interest in another party’s Background IP. 

	
10.2
	
The Customer grants to Fujifilm a royalty-free, worldwide license to use Customer’s Background IP for the exclusive purpose of performance of the Program. Customer warrants that to its knowledge, the use by Fujifilm (or its Authorized Third Parties) of Customer’s Background IP in accordance with this clause 10.2 shall not infringe any third party’s Intellectual Property Rights. 

	
10.3
	
Fujifilm shall not be obliged to deliver any materials (including any cell bank or cell paste) comprising Fujifilm Expression Technology unless and until a license is granted in writing on terms to be agreed under the relevant Background IP.  Fujifilm shall be entitled to charge the Customer for storage of any such materials which would have been delivered under clause 7.2 if a license had been granted under this clause 10.3 until the time that such license is granted. Fujifilm has reviewed the manufacturing process for the Product and warrants that the Process and Product shall not comprise any Fujifilm Expression Technology unless specifically stated in the applicable SoW. 

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FDB Global MSA December 2017

	
10.4
	
All title to and all rights and interest in any Customer Foreground IP and Results shall vest in Customer. Fujifilm hereby assigns to the Customer all title to and all rights and interest in any Customer Foreground IP and Results. 

	
10.5
	
All title to and all rights and interest in any Fujifilm Foreground IP shall vest in Fujifilm.  The Customer hereby assigns to Fujifilm all title to and all rights and interest in any Fujifilm Foreground IP.

	
10.6
	
If requested to do so by  another party, each party shall at the expense of the requesting party execute all documents and do all such further acts as the requesting party may reasonably require to perfect the assignment and give testimony which may be necessary to apply for and obtain patent protection in any country under clause 10.4 or 10.5. 

	
10.7
	
Fujifilm grants to Customer a royalty free, worldwide license to use the Fujifilm Foreground IP for the exclusive purpose of manufacturing the Product and performance of the Program.

	
11.
	
Intellectual Property Indemnity 

	
11.1
	
Fujifilm shall fully Indemnify the Customer from and against all Liabilities incurred by the Customer or its Affiliates arising out of any third party claim that Fujifilm’s use of Fujifilm’s Intellectual Property Rights in performing the Program infringes such third party’s Intellectual Property Rights.

	
11.2
	
The Customer shall fully Indemnify Fujifilm from and against all Liabilities incurred by Fujifilm or its Affiliates arising out of any third party claim that:

	
 
	
11.2.1
	
Fujifilm’s use of (i) materials provided by the Customer to Fujifilm or (ii) Customer’s Intellectual Property Rights, in accordance with this Agreement; or 

	
 
	
11.2.2
	
(excluding Liabilities in relation to which Fujifilm Indemnifies the Customer  pursuant to clause 11.1) the development or manufacture of the Product and/or any other deliverables which are an output of the Program or the use of the Process in accordance with this Agreement,

infringes such third party’s Intellectual Property Rights.

	
11.3
	
If a third party claim is made in accordance with clause 11.1 or 11.2 then the Indemnified Party may require the Indemnifying Party to prove that it has reasonably adequate financial means to pay out under the indemnity provisions provided for in those clauses (for example by way of set aside capital or insurance). If the Indemnifying Party cannot so prove it has the reasonable financial standing to meet its obligations with respect to the Indemnities under the applicable clause then the Indemnified Party (a) may immediately suspend performance of all obligations (other than payment obligations) under this Agreement and SOW and (b) has the option to terminate this Agreement on thirty (30) days’ prior written notice. If Fujifilm exercises its option to terminate under this clause 11.3 then (without prejudice to the survival of the relevant Indemnity obligations) such termination shall be treated as a termination under clause 14.3.2.

	
12.
	
Confidentiality

	
12.1
	
During the term of this Agreement and for a period of ten (10) years after its termination, each party (the “Receiving Party”) agrees with the other (the “Disclosing Party”):

	
 
	
12.1.1
	
to keep the Disclosing Party’s Confidential Information confidential;

	
 
	
12.1.2
	
not to access or use the Disclosing Party’s Confidential Information except for performance of each SoW and acceptance of any deliverables;

	
 
	
12.1.3
	
not to disclose the Disclosing Party’s Confidential Information to a third party other than on a need-to-know basis to the Receiving Party’s:

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FDB Global MSA December 2017

	
 
	
(a)
	
Affiliates; 

	
 
	
(b)
	
officers and employees and those of its Affiliates that need to know the Confidential Information for the purpose of performing its obligations under this Agreement;

	
 
	
(c)
	
contractors and sub-contractors, professional advisers, consultants and agents and those of its Affiliates who are engaged to advise that party in connection with the Program or this Agreement; and 

	
 
	
(d)
	
any other person to whom the Disclosing Party agrees in writing that Confidential Information may be disclosed in connection with the Program,

the “Authorized Third Parties”. The Authorized Third Parties shall be bound by obligations of confidentiality to the Receiving Party at least as stringent as those set forth herein.

	
12.2
	
The Receiving Party shall ensure that each of the Authorized Third Parties complies with obligations of confidentiality and nonuse no less restrictive than those specified hereunder with respect to the Disclosing Party’s Confidential Information and shall remain primarily liable to the Disclosing Party for any act or omission of any of the Authorized Third Parties.

	
12.3
	
The Receiving Party shall within 30 (thirty) days of receipt of the Disclosing Party’s written request (including after termination of this Agreement and any SoW):

	
 
	
12.3.1
	
deliver up to the Disclosing Party all items and copies of all or any Confidential Information of the Disclosing Party;

	
 
	
12.3.2
	
expunge and/or make irretrievable all Confidential Information of the Disclosing Party from any computer or other similar device in which it is stored and, if further requested, certify in writing signed by an authorized representative that it has done the same (provided that this clause 12.3.2 shall not apply to automatically archived electronic files or electronic back-ups made in the ordinary course of business, on secured central servers, which cannot reasonably be deleted and such electronic files shall be retained subject to the obligations of confidence set out in this clause 12); and

	
 
	
12.3.3
	
destroy all hard copies of notes, analyses or memoranda containing the Disclosing Party’s Confidential Information (and, if further requested, certify in writing signed by an authorized representative that it has done the same)

provided that the Receiving Party shall be entitled to retain copies of the Confidential Information to enable it to monitor its obligations under this Agreement or which is required to be maintained by Applicable Laws or a Regulatory Authority subject always to the obligations of confidence under this Agreement.

	
12.4
	
Confidential Information shall not include information which:

	
 
	
12.4.1
	
is, or becomes, generally available to the public other than as a direct or indirect result of the information being disclosed by the Receiving Party or its Authorized Third Parties in breach of this Agreement (except that any compilation of otherwise public information in a form not publicly known shall still be treated as Confidential Information);

	
 
	
12.4.2
	
was available to the Receiving Party on a non-confidential basis prior to disclosure by the Disclosing Party, as evidenced by the Receiving Party’s written records;

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FDB Global MSA December 2017

	
 
	
12.4.3
	
was, is, or becomes available to the Receiving Party on a non-confidential basis from a person who, to the Receiving Party’s knowledge, is not under any confidentiality obligation in respect of that information;

	
 
	
12.4.4
	
was lawfully in the possession of the Receiving Party before the information was disclosed by the Disclosing Party, as evidenced by the Receiving Party’s written records; 

	
 
	
12.4.5
	
is developed by or for the Receiving Party independently of and without use of or reliance upon the information disclosed by the Disclosing Party, as evidenced by the Receiving Party’s written records; 

	
 
	
12.4.6
	
is necessarily disclosed by the Receiving Party pursuant to a statutory or regulatory obligation, but then only to the extent of such required disclosure and save that the Receiving Party shall, to the extent it is lawful to do so, give prompt prior notice to the Disclosing Party of any such potential disclosure and allow the Disclosing Party a reasonable opportunity to limit such disclosure; or

	
 
	
12.4.7
	
the Disclosing Party and the Receiving Party agree in writing is not confidential.

12.5  Notwithstanding anything to the contrary in this Agreement, either party may disclose the existence, terms and conditions of this Agreement IN AN ELECTRONIC DATA ROOM to prospective investors or partners, provided that (a) any such party to whom disclosure is permitted has agreed in writing to keep such information confidential, (b) any such party to whom such disclosure is made is not, in the case of disclosure by Customer, PRIMARILY a contract development and/or manufacturing organization in the biopharmaceutical industry, AND [*]  THE PARTY SHARING THE INFORMATION WITH ITS PROSPECTIVE INVESTORS OR PARTNERS SHALL REMAIN PRIMARILY LIABLE FOR ANY UNAUTHORIZED DISCLSOURE BY SUCH INVESTORS AND PARTNERS.

*Confidential Treatment Requested.

 

	
13.
	
Change

	
13.1
	
If a party wishes to change any aspect of this Agreement or any Scope of Work then the parties shall follow Fujifilm’s standard change process (and such change shall be referred to as a “Change”). Upon determining that a modification to this Agreement or any Scope of Work is required, or requested by Customer, Fujifilm shall draft the Change and the Change will not be effective until signed by both Fujifilm and Customer.

	
14.
	
DELAY, Cancellation, Termination AND CONSEQUENCES

	
14.1
	
Delay: 

	
 
	
14.1.1
	
If the Customer either causes or requests a material delay to any Stage; Stages; or the Program as a whole and that delay prevents, or will prevent, Fujifilm from performing a Stage or the Program as a whole in accordance with the Program Plan (a “Delay”) and the parties cannot agree a Change to accommodate that Delay:

	
 
	
(a)
	
then either the Batch Cancellation Fee(s) or the Program Cancellation Fee (as applicable) shall be payable; and

	
 
	
(a)
	
the Batch Cancellation Fee or Program Cancellation Fee (as applicable) shall be calculated by reference to the date on which notice was given by the Customer in relation to the delay if such notice is given, or the date on which the delay becomes apparent to Fujifilm.

	
 
	
14.1.2
	
If the parties agree a Change to accommodate the Delay and that results in the Delayed Stage(s) or Program (as applicable) being performed partially within the 

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original period reserved for the Delayed Stage(s) or Program as a whole then the Batch Cancellation Fee(s) or the Program Cancellation Fee (as applicable) shall be reduced proportionally to reflect the period of time that the Program was Delayed (as determined by Fujifilm acting reasonably).

	
 
	
14.1.3
	
In the event that Fujifilm successfully books slots vacated by the Customer’s Delay with a substantially equivalent program from a new customer or a substantially equivalent new program for an existing customer, the Customer shall not incur any Batch Cancellation Fee or Program Cancellation Fee (as applicable) associated with such manufacturing slot.

	
14.2
	
Termination of this Agreement as a whole

	
 
	
14.2.1
	
Fujifilm collectively or the Customer shall be entitled to terminate this Agreement (and all Scope of Works made under it) immediately upon giving notice to the other if:

	
 
	
(a)
	
the other party commits a material breach of clauses 8.4, 10, , 12, 19 and such breach:

	
 
	
(i)
	
is not capable of remedy (a breach shall be considered capable of remedy if the party in breach can comply with the provision in question in all respects other than as to time of performance); or

	
 
	
(ii)
	
is capable of remedy, and the breaching party fails to remedy the breach or (except for payment obligations) fails to commence remedy of the breach within sixty (60) days after receipt of notice giving full particulars of the breach and requiring it to be remedied, provided, however, that such cure period shall be suspended during any time that a party seeks resolution of a dispute as to whether an alleged material breach occurred pursuant to clause 16;

	
 
	
(b)
	
the other party takes any step or action in connection with its entering administration, provisional liquidation or any composition or arrangement with its creditors (other than in relation to a solvent restructuring), being wound up (whether voluntarily or by order of the court, unless for the purpose of a solvent restructuring), having a receiver appointed to any of its assets or ceasing to carry on business or, if the step or action is taken in another jurisdiction, in connection with any analogous procedure in the relevant jurisdiction; or

	
 
	
(c)
	
the other party or the person Controlling the other party has a change in Control and the new Controlling entity is reasonably considered by the party giving notice either to be its direct competitor or not to have reasonable financial creditworthiness; provided, however, that any acquirer of the Customer would only be considered a direct competitor to Fujifilm if such acquirer’s primary business was contract manufacturing of biopharmaceuticals.

	
14.3
	
Termination of a Stage/Program by the Customer for Convenience

	
 
	
14.3.1
	
The Customer may cancel a Non-Manufacturing Stage for convenience by giving written notice to Fujifilm in which case:

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(a)
	
the SoW shall terminate in respect of that Stage;

	
 
	
(b)
	
in all other respects the SoW shall continue in full force;

the Customer shall pay Fujifilm the Charges that are due for the Fujifilm Services that have been performed and [*] of the Charges for the Fujifilm Services that have not yet been performed in that Non-Manufacturing Stage plus any Charges owed in respect of Ancillary Services that have been performed.

*Confidential Treatment Requested.

 

	
 
	
14.3.2
	
The Customer may cancel any Manufacturing Stage for convenience by giving written notice to Fujifilm in which case:

	
 
	
(a)
	
the SoW shall terminate in respect of that Stage;

	
 
	
(b)
	
in all other respects the SoW shall continue in full force;

	
 
	
(c)
	
the Customer shall pay the Charges that are due for the Fujifilm Services that have been performed and the relevant Batch Cancellation Fee plus any Charges owed in respect of Ancillary Services that have been performed.

	
 
	
14.3.3
	
The Customer may cancel a Program for convenience by giving written notice to Fujifilm in which case:

	
 
	
(a)
	
the SoW(s) in respect of that Program shall terminate;

	
 
	
(b)
	
the Customer shall pay the Charges that are due for the Fujifilm Services that have been performed and the Program Cancellation Fee plus any Charges owed in respect of Ancillary Services that have been performed.

	
 
	
14.3.4
	
If a critical Stage, or more than one Stage, under a Program is cancelled and that has the effect of cancelling a Program as a whole (as determined by Fujifilm acting reasonably) then clause 14.3.3 shall apply instead of clauses 14.3.1 and/or 14.3.2 . 

	
14.4
	
Termination by Fujifilm for an Unforeseen Technical Factor

	
 
	
14.4.1
	
If an Unforeseen Technical Factor occurs, and the parties are unable to agree to a Change to accommodate that Unforeseen Technical Factor, Fujifilm may terminate any affected Program without any liability to Customer by giving prior written notice to the Customer if Fujifilm reasonably believes that it will be unable to carry out and complete such Program in accordance with the Scope of Work due to the Unforeseen Technical Factor. 

	
 
	
14.4.2
	
[*]

	
14.5
	
Termination of a Scope of Work for Breach

	
 
	
14.5.1
	
If any party commits a material breach of a Scope of Work, the non-breaching party may give written notice to the other party, specifying the nature of the material breach and, if such material breach is not remedied within sixty (60) days or (other than payment obligations) a remedy is not commenced within sixty (60) days after receipt of such notice (provided, however, that the cure period shall be suspended during any time that a party seeks resolution of a dispute as to whether an alleged material 

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FDB Global MSA December 2017

	
 
		
breach occurred pursuant to clause 16), then the non-breaching party shall have the right, in its sole discretion, to immediately terminate that Scope of Work.

	
 
	
14.5.2
	
If Fujifilm terminates a Scope of Work under this clause 14.5 or all Scopes of Work under clause 14.2 then, without prejudice to Fujifilm’s other rights and remedies, the Program Cancellation Fee shall be payable by the Customer to Fujifilm plus any Charges owed in respect of Ancillary Services that have been performed.

	
14.6
	
If a party exercises any of its rights of termination in respect of only one or more SoWs then:

	
 
	
14.6.1
	
this Agreement shall terminate in respect of those SoWs and the provisions of this Agreement relating to termination of this Agreement shall apply in relation to those SoWs; and

	
 
	
14.6.2
	
in all other respects this Agreement shall continue in full force and those SoWs in respect of which the party has terminated this Agreement will be deemed to be removed from the definition of the SoWs.

	
14.7
	
Additional Consequences of Termination 

	
 
	
14.7.1
	
Upon receipt of a notice of termination, Fujifilm shall make prompt, reasonable efforts to limit or terminate all outstanding costs and expenses related to provision of the Services and/or manufacture of the Product. 

	
 
	
14.7.2
	
The termination of this Agreement or any Scope of Work shall be without prejudice to the rights and remedies of any party which may have accrued up to the date of termination.

	
 
	
14.7.3
	
On termination of this Agreement or any SoW (as applicable) for any reason whatsoever:

	
 
	
(a)
	
Fujifilm shall provide all Materials and Results (in .pdf format) to Customer except as Fujifilm is required to retain under Applicable Laws, and Customer shall reimburse Fujifilm for associated reasonable, documented costs;

	
 
	
(b)
	
save as set out in clause 10 the relationship of the parties shall cease and any rights or licenses granted under or pursuant to this Agreement shall cease to have effect save as (and to the extent) expressly provided for in this clause 14;

	
 
	
(c)
	
the provisions of the following clauses together with any provision which expressly or by implication is intended to come into or remain in force on or after termination shall continue in full force and effect clauses 1, 4.3, 8, 9, 10, 11, 129, 14, 16, 18, and 22; and

[*]

*Confidential Treatment Requested.

 

	
15.
	
Force Majeure

	
15.1
	
Subject to clause 15.2, no party shall be liable to the other(s) for any delay or non-performance of its obligations under any Scope of Work (except for the payment of money) arising from a Force Majeure Event.

	
15.2
	
If a party is delayed or prevented from performing its obligations due to a Force Majeure Event such party shall:

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FDB Global MSA December 2017

	
 
	
15.2.1
	
give notice of such Force Majeure Event to the non-affected parties as soon as reasonably practical stating the commencement date and extent of such delay or prevention, the cause thereof and its estimated duration;

	
 
	
15.2.2
	
use reasonable endeavors to mitigate the effects of such Force Majeure Event; and

	
 
	
15.2.3
	
resume performance of its obligations as soon as reasonably practicable. 

	
15.3
	
If the Force Majeure Event in question continues for more than 3 (three) months any party to the affected Scope of Work may give notice in writing to the other(s) to terminate that Scope of Work. The notice to terminate must specify the termination date, which must not be less than ten (10)) Business Days after the date on which the notice is given, and once such notice has been validly given, that Scope of Work will terminate on that termination date.

	
16.
	
Dispute Resolution

	
16.1
	
If there is a dispute in relation to or in connection with the QA Documents, such dispute shall be dealt with in accordance with the procedures set out in the Quality Agreement.

	
16.2
	
In respect of any dispute concerning this Agreement (other than a dispute in connection with the QA Documents) the parties shall seek to resolve the matter as follows:

	
 
	
16.2.1
	
by referral in writing summarizing the nature of the dispute by a party in the first instance to the decision of each party’s Program Manager; 

	
 
	
16.2.2
	
if the dispute is not resolved within 10 (ten) Business Days of its referral to the Program Managers it shall be referred to the decision of Fujifilm’s SVP of Program Management and the Customer’s President or Chief Executive Officer; and 

	
 
	
16.2.3
	
if the dispute is not resolved within 10 (ten) Business Days of its referral to Fujifilm’s SVP of Program Management and the Customer’s President or Chief Executive Officer it shall be referred to the decision of each party’s President or Chief Executive Officer (as applicable/appropriate).

	
16.3
	
Binding Arbitration.  Except with respect to any matters involving confidentiality and/or intellectual property, if the dispute between the parties is not resolved having applied the process set out at clause 16.2 then the dispute shall be settled solely and exclusively by arbitration in accordance with the Comprehensive Arbitration Rules and Procedures of JAMS, upon application of either party.  Unless otherwise agreed by the parties, the arbitration shall be conducted New York City, NY. before a panel of three arbitrators each of whom is experienced and knowledgeable in the pharmaceutical manufacturing industry, and at least one of the arbitrators will be an attorney.  One arbitrator will be appointed by each party to serve on the panel.  One neutral arbitrator will be appointed by the two arbitrators.  If the two arbitrators selected cannot agree on the appointment of the third arbitrator within twenty (20) days of their appointment, or if either party shall fail to appoint its arbitrator within twenty (20) days after receipt of notice of demand for arbitration, such arbitrator(s) not appointed shall be selected and appointed by JAMS upon application of either party. The costs and expenses of each arbitration hereunder and their apportionment between the parties will be determined by the arbitrators in their award or decision.  Judgment upon any award of the majority of the arbitrators shall be final, binding and conclusive, and may be entered upon the motion of either party in a court of competent jurisdiction. 

	
16.4
	
Notwithstanding the provisions of this clause 16 any party may commence or take proceedings or seek remedies before the courts or any other competent authority for interim, interlocutory, injunctive or other equitable remedies in relation to this Agreement.

	
17.
	
Audit

	
17.1
	
The Customer may carry out audits at the times, and in accordance with the terms, set out in the Quality Agreement provided that access by the Customer and/or its representatives to 

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FDB Global MSA December 2017

		
records, information and systems shall be on a supervised basis, subject to the Customer complying with the security and confidentiality requirements of Fujifilm to protect information which relates to anything other than the Programs and shall be limited to those days as stated in the Quality Agreement 

	
17.2
	
Audit access shall not be extended to Fujifilm’s confidential records, including details of financial transactions and contracts with third parties that relate to this Agreement.

	
17.3
	
If Fujifilm is in material breach of this Agreement or if the Customer reasonably believes that Fujifilm is in material breach of this Agreement, the Customer may upon giving reasonable written notice to Fujifilm carry out an audit on the same basis as in clauses 17.1 and 17.2.

	
17.4
	
Additional audits (other than those carried out pursuant to clause 17.1 and 17.2) may be carried out on the same basis as in clauses 17.1 and 17.2 subject to (i) payment of Fujifilm’s costs and expenses and the agreement of a commercial rate; and (ii) the Customer ensuring such audit will not delay or disrupt Fujifilm’s operations at the Facility.

	
18.
	
Notices

	
18.1
	
Subject to clause 18.2 the parties may communicate with each other in any way that is normal in the course of their business.

	
18.2
	
Any notice given under clauses 3, 8, 9, 11, 12, 14, 15, 16, 17, 18.2, 19 or  20 shall only be effective if it is in writing, sent to a party at its address or email address and for the attention of the individual, as set out in Schedule 2 (or such other address, email address or individual as that party may notify the other in accordance with this clause 18) and is given in accordance with clauses 18.3 to 18.5 below.

	
18.3
	
Where a notice must be given to Fujifilm under clauses 3.2, 14 or 20.2 such notice must be given to FBDK, FBDT and FDBU.

	
18.4
	
Notice may be given by hand or sent by email (with confirmation by another form of notice provided hereunder), recorded delivery, registered post or airmail and will be deemed to have been duly served:

	
 
	
18.4.1
	
if delivered by hand, at the time and date of delivery;

	
 
	
18.4.2
	
if sent by email, at the time and date of sending;

	
 
	
18.4.3
	
if sent by recorded delivery or registered post, 48 (forty eight) hours from the date of posting (such date as evidenced by postal receipt); and

	
 
	
18.4.4
	
if sent by registered airmail, five days from the date of posting,

provided that, where in the case of delivery by hand or transmission by email, such delivery or transmission occurs either after 4.00pm on a Business Day, or on a day other than a Business Day, service will be deemed to occur at 9.00am on the next Business Day.

	
18.5
	
In proving service of a notice it will be sufficient to prove that delivery was made or that the envelope containing the notice or document was properly addressed and posted (either by prepaid first class recorded delivery post or by prepaid airmail, as the case may be) or that no failed delivery message was received, as the case may be.

	
19.
	
Export Controls, MODERN SLAVERY AND CORRUPTION

	
19.1
	
The Customer acknowledges that export and/or use of any Product may be subject to compliance with laws, rules and regulations of bodies having jurisdiction over such operations. 

25

 

 

FDB Global MSA December 2017

		
If the export or use of any Products is so controlled, it is the responsibility of the Customer to obtain any such approval required by any applicable laws, rules or regulations.

	
19.2
	
Each party shall endeavour to hold itself and its suppliers to the highest performance, ethical and compliance standards, including basic human rights, not engaging in any activity, practice or conduct which would constitute an offence under anti-slavery legislation in the United Kingdom or the U.S.A, encouraging fair and equal treatment for all persons, the provision of safe and healthy working conditions, respect for the environment, the adoption of appropriate management systems and the conduct of business in an ethical manner.  In performing its duties under this Agreement, each party acknowledges the value and importance of performance and ethical behaviour in its performance under this Agreement.

	
19.3
	
Each party warrants that on the Effective Date and each SoW Effective Date, it, its directors, officers or employees have not offered, promised, given, authorized, solicited or accepted any undue pecuniary or other advantage of any kind (or implied that they will or might do any such thing at any time in the future) in any way connected with this Agreement or a SoW and that it has taken reasonable measures to prevent subcontractors, agents or other third parties, subject to its control or determining influence, from doing so.

	
19.4
	
The parties agree that, at all times in connection with and throughout the term of this Agreement, they will comply with and that they will take reasonable measures to ensure that their subcontractors, agents or other third parties will comply with all applicable anti-corruption legislation including the Bribery Act 2010 or the Foreign Corrupt Practices Act 1977.

	
19.5
	
Each party shall not do, or omit to do, any act that would cause one of the other parties to be in breach of any anti-corruption legislation including the Bribery Act 2010 or the Foreign Corrupt Practices Act 1977.

	
20.
	
Assignment AND SUB-CONTRACTING

	
20.1
	
A party may assign or transfer all of its rights and responsibilities under this Agreement to:

	
 
	
20.1.1
	
an Affiliate provided that such Affiliate has reasonable financial creditworthiness; or 

	
 
	
20.1.2
	
a purchaser of all or substantially all of the equity of the assigning party provided that such third party has reasonable financial creditworthiness; or 

	
 
	
20.1.3
	
a purchaser of all or substantially all of assets to which this Agreement relates provided that such third party has reasonable financial creditworthiness,

but not otherwise without written consent of the other parties (such consent not to be unreasonably withheld or delayed) and provided that  (a) the assignee agrees in writing to assume all obligations undertaken by its assignor in this Agreement and (b) in relation to assignment in part no such assignment shall relieve the assigning party of responsibility for the performance of any of its obligations under this Agreement.

	
20.2
	
If a party assigns or transfers all or any of its rights and responsibilities under clause 20.1 it shall promptly notify the other parties in writing. 

	
20.3
	
Fujifilm may sub-contract all or any of its obligations under this Agreement provided that in relation to any subcontracting of any activities that involve manufacture, processing, handling, analytical testing of Product, storage of Product, or any other cGMP activities contracted by the parties relating to the Product, Fujifilm will obtain the Customer’s prior written consent (which may be by signature of the relevant SoW(s) which specify that an obligation will be sub-contracted).  By way of clarity, Fujifilm shall not be obligated to obtain Customer’s prior consent for subcontracting services related to facility maintenance, cleaning, equipment validation, raw material testing and similar services. 

	
20.4
	
The appointment of any subcontractor shall not relieve the party sub-contracting from any liability or obligation under this Agreement and the party sub-contracting shall be responsible 

26

 

 

FDB Global MSA December 2017

		
for all acts and omissions of the subcontractor to the same extent as if they were its own acts or omissions.

	
21.
	
General

	
21.1
	
Entire agreement: This Agreement contains all the terms which the parties have agreed with respect to the subject matter herein and supersedes all previous agreements and understandings between the parties (whether oral or in writing) relating to such subject matter. Each party acknowledges and agrees that it has not been induced to enter into this Agreement by a statement or promise which it does not contain. Each party confirms that save as otherwise expressly set out in this Agreement, the other party gives no warranties either in this Agreement or elsewhere in connection with the provision of the Programs. Nothing in this clause 21.1 shall exclude or limit a party’s liability for fraud, including fraudulent misrepresentation. 

	
21.2
	
Third party rights: Save as expressly set out in this Agreement, the parties do not intend that any person who is not a party to this Agreement shall have any right to enjoy the benefit or enforce any of the terms of this Agreement.

	
21.3
	
Amendments: With the exception of Changes, which shall be subject to clause 0, no amendment to this Agreement shall be valid unless in writing and signed by a duly authorized representative of each of the parties. A party is entitled to assume that a representative of another party is authorized to act on that party’s behalf if that individual is apparently or seemingly acting in the normal course of the business relationship. An exchange of emails shall not be capable of constituting an agreement to amend this Agreement.

	
21.4
	
Waiver: No failure or delay by a party to exercise any right or remedy provided under this Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. The single or partial exercise by any party of any right, power or remedy under this Agreement shall not in any circumstances preclude any other or further exercise of it, or the exercise of any right, power or remedy. A waiver by any party of a breach of any provision of this Agreement shall not be considered as a waiver of a subsequent breach of the same or any other provision of this Agreement.

	
21.5
	
Severability: If any provision of this Agreement or a SoW is found by any court or administrative body of competent jurisdiction to be invalid, illegal or unenforceable in any jurisdiction then it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible that provision shall be deemed to be omitted from this Agreement or the SoW in so far as this Agreement or that SoW relates to that jurisdiction and the validity and enforceability of that provision in other jurisdictions and the other provisions of this Agreement or SoW shall not be affected or impaired.

	
21.6
	
Counterparts: This Agreement may be executed in any number of counterparts. Any party may enter into this Agreement by executing a counterpart and all the counterparts taken together will constitute one and the same agreement. This Agreement shall not be effective until each party has signed one counterpart.

	
21.7
	
Publicity: The parties agree that, except as necessary to comply with Applicable Laws, no party shall make any official press release, public announcement or other formal publicity relating to the transactions which are the subject of this Agreement, without first obtaining in each case the prior written consent of the other parties, which consent shall not be unreasonably withheld.  If a party is required under any securities laws or regulations to disclose the terms of this Agreement (in summary, in whole or in part), such party shall provide a redacted version of the disclosure to the other party and give such other party adequate time to review and propose further redactions.  The parties shall work in good faith to redact confidential and proprietary information of each party prior to such required disclosure.

	
21.8
	
Independent Contractors: Nothing in this Agreement shall create, or be deemed to create, a partnership or the relationship of principal and agent or employer and employee between the 

27

 

 

FDB Global MSA December 2017

		
parties. Each party agrees to perform under this Agreement solely as an independent contractor.

	
21.9
	
Duty to Mitigate: Each of the parties shall use all reasonable endeavors to mitigate any costs, losses or expenses due to be incurred or suffered by the other party in connection with the performance or non-performance of this Agreement.

	
22.
	
Governing Law 

	
22.1
	
The formation, existence, construction, performance, validity and all aspects whatsoever of this Agreement (including any Scope of Work) or any term of it and any issues, disputes or claims arising out of or in connection with it (whether contractual or non-contractual in nature) shall be governed by, and construed in accordance with, the State of Delaware, without regard to conflicts of law provisions. Subject to clause 16, the parties hereby submit to the jurisdiction of the Delaware courts, both state and federal, in all matters concerning this Agreement. 

IN WITNESS of the above the parties have signed this Agreement on the date of last signature below.

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FDB Global MSA December 2017

	
Schedule 1
	
Charges 

In addition to the Charges for the Fujifilm Services (as the same are described in the relevant Scope of Work); the Customer will pay to Fujifilm Charges in consideration of the research and development and technical consultancy services in relation to the procurement, testing and management of Consumables; Subcontracted Work (including delivery of material to and from such subcontractors); Process-Specific Equipment (including installation and qualification thereof); Modifications; and Special Waste (the “Ancillary Services”) as calculated in accordance with this Schedule 1.

	
1.
	
Charges for Consumables in Non-Manufacturing Stage and Manufacturing Stage 

At the time set out in the Scope of Work, or in the course of the Program as mutually agreed in writing by the parties, the Customer shall pay to Fujifilm an amount in advance in consideration of the Ancillary Services relating to the purchase of Consumables intended to be used during the applicable Non-Manufacturing Stages and Manufacturing Stages. This will be an amount based upon an estimation of the sums required to purchase Consumables based upon Fujifilm’s historical data from previous manufactures at the applicable scale of production plus [*] of such sums [*], (the “Consumables Advance Payment”).

*Confidential Treatment Requested.

 

	
1.2
	
On completion of each Non-Manufacturing Stage or Manufacturing Stage, Fujifilm shall calculate the expenditure incurred in respect of Consumables procured for use during such Non-Manufacturing Stage or Manufacturing Stage and shall add a sum equivalent to [*] of all such expenditure on to such sum [*], the aggregate amount being referred to as “Actual Production Expenditure”.

	
1.3
	
If the Actual Production Expenditure is greater than the Consumables Advance Payment, Fujifilm shall issue a further invoice for the Ancillary Services in relation to the Consumables for a sum equivalent to the difference. If the Actual Production Expenditure is less than the Consumables Advance Payment, Fujifilm shall issue a credit note against the earlier invoice for a sum equivalent to the difference to be applied to the Charges for the following Stage (if there is one).

	
1.4
	
Each month, Fujifilm shall issue an invoice to the Customer in relation to the Ancillary Services regarding any Consumables used during any Stage during the previous month in amounts which are not covered in paragraphs 1.2 and 1.3 above equivalent to the expenditure on such additional Consumables during the previous month plus an amount equal to [*] of such expenditure.

	
2.
	
Additional Charges in Respect of Subcontracted Work, Process-Specific Equipment, Modifications and Special Waste

	
2.1
	
Fujifilm shall obtain the Customer’s approval in writing prior to incurring expenditure on Ancillary Services relating to Subcontracted Work, Process-Specific Equipment, Modifications and disposal of Special Waste.

	
2.2
	
If approved by the Customer under paragraph 2.1, Fujifilm shall bear such expenditure itself.

	
2.3
	
Fujifilm shall invoice the Customer for the Ancillary Services relating to the Subcontracted Work, Process-Specific Equipment, Modifications and disposal of Special Waste as the case may be in the same amount as the expenditure which Fujifilm incurs in respect of such Ancillary Services plus a sum equivalent to [*] of such expenditure.

	
2.4
	
Fujifilm shall issue invoices for such Ancillary Services either at the time Fujifilm incurs expenditure in respect of the Subcontracted Work, Process-Specific Equipment, Modifications and/or disposal of Special Waste or as set out in the relevant SoW as the case may be.

 

 

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FDB Global MSA December 2017

	
3.
	
Purchase of Process-Specific Consumables and Process-Specific Equipment by the Customer on completion of the relevant Stage or termination

Subject to clause 10.3 and the payment of all relevant Charges, the Customer shall have an option to purchase from Fujifilm such Process-Specific Equipment and/or Process-Specific Consumables purchased by Fujifilm under paragraphs 1 and 2 of this Schedule 1 as remain following completion of the relevant Stage for which such Process-Specific Equipment and/or Process-Specific Consumables were purchased for consideration of [*] payable, if the work is performed in the UK or USA respectively, at the time of such sale.

*Confidential Treatment Requested.

 

	
3.2
	
The option in paragraph 3.1 shall be exercised within 2 (two) months following completion of the relevant Stage under which such Process-Specific Equipment and/or Process-Specific Consumables were purchased or termination of this Agreement, (whichever occurs first). 

	
3.3
	
The Customer shall be responsible for any cost and expense associated with removal/delivery of such Process-Specific Equipment and/or Process-Specific Consumables and documenting such sale. Such Process-Specific Equipment and/or Process-Specific Consumables shall be delivered Ex Works the Facility (Incoterms 2010). Risk in and title to such Process-Specific Equipment and/or Process-Specific Consumables shall pass on delivery. 

	
3.4
	
Upon [*] prior written notice to the Customer, Fujifilm shall be free to use or destroy (at the Customer’s cost) any item(s) of Process-Specific Equipment or Process-Specific Consumables in respect of which the option referred to in this paragraph 333 is not exercised or for which their assigned expiry date has passed.

	
4.
	
Product Samples, Cell Banks and other materials on completion or termination

	
4.1
	
Prior to completion of each Program, the Customer shall notify Fujifilm what (if any) samples and/or cell banks used during the Program the Customer wishes Fujifilm to deliver to the Customer and, subject to clause 10.3, delivery of those samples/cell banks shall take place in accordance with clause 7. If the Customer does not give any such notification to Fujifilm prior to completion of the Program, Fujifilm may destroy such samples and/or cell banks at the Customer’s cost upon thirty (30) days’ prior written notice to the Customer.

	
4.2
	
Upon [*] prior written notice to the Customer, Fujifilm shall be entitled, in a manner of its choosing and without further notice to the Customer, to dispose of any Product, samples, cell banks or other property of the Customer which remains in the possession of Fujifilm in [*] following the effective date of termination.

	
5.
	
Batch Cancellation Fees

	
5.1
	
The Batch Cancellation Fee shall be: 

	
 
	
5.1.1
	
the applicable [*] and associated Disposition Fees (detailed in the SoW) set out in the table below, which will reflect the [*] between:

	
 
	
(a)
	
notice of cancellation of such Batch(es); and

	
 
	
(b)
	
the then current date for [*];

	
 
	
5.1.2
	
less any sums already received under the SoW for the Fujifilm Services in relation to the cancelled Batch(es) that have not been performed at the time the Batch Cancellation Fee is calculated.

	
5.2
	
[*] payable:

		
	
[*]
	
[*]

	
[*]
	
[*]

30

 

 

FDB Global MSA December 2017

		
	
[*]
	
[*]

	
[*]
	
[*]

*Confidential Treatment Requested.

 
 

	
6.
	
Program Cancellation Fees

	
6.1
	
The Program Cancellation Fee shall be: 

	
 
	
6.1.1
	
the applicable [*] (detailed in the SoW(s)) that is being cancelled set out in the table below, which will reflect the [*] between:

	
 
	
(a)
	
notice of cancellation of the Program; and

	
 
	
(b)
	
the then current date for [*]

	
 
	
6.1.2
	
less any sums already received under the SoW(s) for the Fujifilm Services in relation to the cancelled element of the Program that have not been performed at the time the program Cancellation Fee is calculated.

	
6.2
	
[*] payable:

		
	
[*]
	
[*]

	
[*]
	
[*]

	
[*]
	
[*]

	
[*]
	
[*]

 

 

31

 

 

FDB Global MSA December 2017

	
Schedule 2
	
Addresses for Notice

 

		
	
FDBK:

Contact: Chief Operating Officer

Address: FUJIFILM Diosynth Biotechnologies UK Limited, Belasis Avenue, Billingham, TS23 1LH

Nominated email address:

 
	
Copied to:

Contact: Legal Counsel

Address: Fujifilm Diosynth Biotechnologies, Belasis Avenue, Billingham, TS23 1LH, England

Nominated email address: fdbklegal@fujifilm.com

	
FDBT:

Contact: Chief Operating Officer

Address: FUJIFILM Diosynth Biotechnologies Texas, LLC 100 Discovery Drive, Suite 200 College Station, Texas, 77845

Nominated email address:

 
	
Copied to:

Contact: Legal Department

Address: FUJIFILM Holdings America Corporation, 200 Summit Lake Drive, Valhalla, NY 10595.

Nominated email address: legaldepartment@fujifilm.com 

	
FDBU:

Contact: President

Address:FUJIFILM Diosynth Biotechnologies U.S.A., Inc.  101 J. Morris Commons Lane, Morrisville, NC 27560

Nominated email address:

 
	
Copied to:

Contact: Legal Department

Address: FUJIFILM Holdings America Corporation, 200 Summit Lake Drive, Valhalla, NY 10595.

Nominated email address: legaldepartment@fujifilm.com

	
Customer:

Contact:

Address:

Nominated email address:
	
 

President & Chief Executive Officer

Aeglea BioTherapeutics, Inc., 901 S. Mopac Expressway, Barton Oaks Plaza One, Suite 250, Austin, TX   78746

 

32

 

 

FDB Global MSA December 2017

Signature Page

 

SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES TEXAS, LLC:

		
	
 

Signature:/s/ Gerry Farrell
Gerry Farrell

 

Title:  COO

 

Date:  11 NOV 18

 
	
 

Signature:

 

Title:  N/A /s/ GF

 

Date:  11/11/18

 

 

 

SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A., INC:

		
	
Signature:/s/ Andy Fenny
A Fenny

 

Title:  C.B.O

 

Date:  07 Nov 18

 
	
Signature:

 

Title:  N/A /s/ Andy Fenny

 

Date:  

 

 

SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED:

		
	
Signature:/s/ Paul Found
Paul Found

 

Title:  COO

 

Date: 12 NOV 2018

 

 
	
 

 

33

 

 

FDB Global MSA December 2017

SIGNED for and on behalf of AEGLEA BIOTHERAPEUTICS, INC.:

 

		
	
Signature:/s/ Leslie Sloan

 

Title:  SVP, Operations

 

Date:  11-26-18

 
	
Signature:  /s/ Charles York

 

Title:  CFO

 

Date:  26-nov-2018

 

 

 

34

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