Document:

prtk-ex103_423.htm

Exhibit 10.3

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

 

																
	
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
	
1. CONTRACT ID CODE
	
PAGE OF PAGES

	
 
	
1
	
4

	
2. AMENDMENT/MODIFICATION NO.
	
3. EFFECTIVE DATE
	
4. REQUISITION/PURCHASE REQ. NO.
	
5. PROJECT NO. (If applicable)

	
P00003
	
See Block 16C
	
[***]
	
 

	
6. ISSUED BY
	
CODE
	
ASPR-BARDA
	
7. ADMINISTERED BY (If other than Item 6)
	
CODE
	
ASPR-BARDA

	
ASPR-BARDA

200 Independence Ave., S.W.

Room 640-G

Washington DC 20201
	
ASPR-BARDA

US DEPT OF HEALTH & HUMAN SERVICES

BIOMEDICAL ADVANCED RESEACH & DEVELOPMENT AUT

200 INDEPENDENCE AVE, S.W.

Washington DC 20201

 

	
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
	
(x)
	
9A. AMENDMENT OF SOLICITATION NO.

	
PARATEK PHARMACEUTICALS INC 1549007

PARATEK PHARMACEUTICALS, INC.

75 PARK PLZ FL 4

BOSTON MA 021163934
	
 
	
 

	
9B. DATED (SEE ITEM 11)

	
 

	
x
	
10A. MODIFICATION OF CONTRACT/ORDER NO.

	
75A50120C00001

	
10B. DATED (SEE ITEM 13)

	
CODE
	
1549007
	
FACILITY CODE
	
 
	
12/18/2019

	
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

	
☐The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers                             ☐ is extended.   ☐   is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing
Items 8 and 15, and returning        ___________    copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By
separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR
OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided
each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

	
12. ACCOUNTING AND APPROPRIATION DATA (If required)
	
Net Increase:$31,574,667.00

	
2021.1991073.25106
	
 

	
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	
CHECK ONE
	
A.THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

	
 

	
 
	
 

	
 
	
B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

	
 

	
 
	
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

	
 

	
 
	
D. OTHER (Specify type of modification and authority)

	
X
	
FAR 52.217-9 Option to Extend the Term of the Contract & FAR 43.103(a) Mutual Agreement of the Parties

	
E. IMPORTANT:
	
Contractor☐ is not☒ is required to sign this document and return                                1      copies to the issuing office.

	
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

	
Tax ID Number: 33-0960223

DUNS Number: 076333934

The purpose of this modification is to exercise Option 2 and modify ARTICLE B.3. OPTIONS, ARTICLE C.1. STATEMENT OF WORK, ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR), and SECTION J LIST OF ATTACHMENTS accordingly.

Funds Obligated Prior to this Modification: $ 156,634,174

Funds Obligated with Mod #3: $ 31,574,667

Total Funds Obligated to Date: $ 188,208,841

Appr. Yr.: 2021 CAN: 1991073 Object Class: 25106

Change Item 3 to read as follows(amount shown is Continued ...

	
Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect.

	
15A. NAME AND TITLE OF SIGNER (Type or print)
	
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

	
[***]
	
[***]

	
15B. CONTRACTOR/OFFEROR
	
15C. DATE SIGNED
	
16B. UNITED STATES OF AMERICA
	
16C. DATE SIGNED

	
 /s/ [***]              

(Signature of person authorized to sign)         
	
9/23/2021
	
/s/ [***]

(Signature of Contracting Officer)
	
2021.09.23

 

108922677_14

 

 

										
	
CONTINUATION SHEET
	
REFERENCE NO. OF DOCUMENT BEING CONTINUED
	
PAGE
	
  OF

	
 
	
 
	
 
	
 

	
75A50120C00001/P00003
	
2
	
 
	
4

	
NAME OF OFFEROR OR CONTRACTOR

	
PARATEK PHARMACEUTICALS INC 1549007

	
ITEM NO.
	
SUPPLIES/SERVICES
	
QUANTITY
	
UNIT
	
UNIT PRICE
	
AMOUNT

	
(A)
	
(B)
	
(C)
	
(D)
	
(E)
	
(F)

	
3
	
the obligated amount) :

CLIN 0003 SUPPLEMENTAL DEVELOPMENT TO SUPPORT EUA

OR LICENSURE OF TREATMENT and/or PEP OF ANTHRAX

Obligated Amount: $31,574,667.00

Award Type: Cost-plus-fixed-fee

Total Estimated Cost:       $[***]

Fixed Fee:        $[***]

Completion Form

Period of Performance: 09/30/2021 to [***]
	
 
	
 
	
 
	
31,574,667.00

 

 

108922677_14

			
	
Contract No. 75A50120C00001

Modification No. 00003
	
Continuation Sheet

Block 14
	
Page 3 of 4

 

 

 

Total Obligated Funding

				
	
Obligated Funding - Cost Reimbursement CLINs

	
 
	
Cost
	
Fee
	
CPFF

	
CLIN 0001 (Base Award)
	
[***]
	
[***]
	
$21,525,559.00

	
CLIN 0003 (P00003)
	
[***]
	
[***]
	
$31,574,667.00

	
CLIN 0004 (P00001)
	
[***]
	
[***]
	
$20,435,260.00

	
CLIN 0005 (P00001)
	
[***]
	
[***]
	
$76,774,872.00

	
CLIN 0009 (P00002)
	
[***]
	
[***]
	
$43,483.00

	
Subtotal
	
[***]
	
[***]
	
$150,353,841.00

 

		
	
Obligated Funding - Fixed Price CLINs

	
 
	
FFP

	
CLIN 0002 (Base Award)
	
$37,855,000.00

 

		
	
Total Funded
	
$188,208,841.00

ARTICLE B.3. OPTIONS, is modified as follows:

						
	
Optional Cost Reimbursement CLINs

	
CLIN
	
Period of Performance
	
Supplies/ Services
	
Total Est.
Cost
	
Fixed Fee
	
Total Cost Plus
Fixed Fee ($)

	
0003

(Option)
	
09/30/2021 – [***]
	
Supplemental development
to support EUA or licensure
of treatment and/or PEP of
anthrax
	
[***]
	
[***]
	
$31,574,667

(Funded)

	
0004

(Option)
	
04/01/2020 – [***]
	
BARDA Security Requirements
	
[***]
	
[***]
	
$20,435,260

(Funded)

	
0005

(Option)
	
04/01/2020 – [***]
	
Post-Marketing Study
Commitments/ Requirements
for the authorized commercial
indication including relabeling
of approved drug in the
ASPR[***] or VMI (this is an
option that may or may not be
exercised as required by the
FDA)
	
[***]
	
[***]
	
$76,774,872

(Funded)

	
0009

(Option)
	
07/30/2021 – [***]
	
Emergency Distribution of
Procured Antibiotics from VMI
	
[***]
	
[***]
	
$43,483.00

(Funded)

 

108922677_14

			
	
Contract No. 75A50120C00001

Modification No. 00003
	
Continuation Sheet

Block 14
	
Page 4 of 4

 

 

 

ARTICLE C.1. STATEMENT OF WORK is modified as follows:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work set forth in SECTION J - List of Attachments, attached hereto and made a part of the contract.

ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR), is modified as follows:

The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:

[***]

Contracting Officer’s Representative

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

[***]

The following Contracting Officer’s Representative (COR) will represent the Government as an Alternate COR for the purpose of this contract:

[***]

Contracting Officer’s Representative

Chief Antibacterials Branch

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

[***]

Mailing Address:

200 C St.

O’Neill House Office Building (BARDA)

Washington, D.C. 20515

The alternate COR is responsible for carrying out the duties of the COR in the event that the COR can no longer perform his/her duties as assigned.

SECTION J – LIST OF ATTACHMENTS, is modified as follows:

1.Statement of Work, dated September 9, 2021, 11 pages

All other terms and conditions of this contract remain unchanged and in full force and effect.

END OF MODIFICATION P00003 to 75A50120C00001

 

108922677_14

 

 

ATTACHMENT 1

Statement of Work
Contract# 75A50120C00001
Date: 09/09/2021

PREAMBLE

Independently and not as an agency of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work.

The Government reserves the right to modify the milestones, progress, schedule, budget, or deliverables to add or delete deliverables, process, or schedules if the need arises. Because of the nature of this research and development (R&D) contract and the complexities inherent in this and prior programs, at designated milestones the Government will evaluate whether work should be redirected, removed, or whether schedule or budget adjustments should be made. The Government reserves the right to change the product, process, schedule, or events to add or delete part or all of these elements as the need arises.

Overall Objectives and Scope

The overall objective of this contract is to procure an antibiotic that can be used under Emergency Use Authorization (EUA) pre-approval or marketing authorization for the treatment and/or post-exposure prophylaxis treatment of pulmonary anthrax. The Contractor will develop NUZYRA® for Animal Rule licensure, with the objective of making it suitable for stockpiling and use to treat infections with B. anthracis. Once suitable regulatory authorization has been achieved or under an applicable stockpiling authority, NUZYRA® will be purchased and delivered to the [***] or these supplies will become part of a VMI program managed by Paratek. Optional objectives cover activities to help secure the NUZYRA® supply chain, activities to support the commercial sustainability of NUZYRA® with the objective to ensuring continued supply, activities intended to expand the Animal Rule licenses of NUZYRA®, and further purchases for VMI managed by Paratek. The scope of work for this contract includes preclinical, clinical, manufacturing and procurement activities that fall into the following areas: nonclinical activities; clinical activities; manufacturing activities; procurement activities and all associated regulatory, quality assurance, management, and administrative activities. The Research and Development (R&D) efforts and procurement of NUZYRA® will progress in specific stages that cover the base performance (CLINs 1 and 2) segment and six (6) option segments (CLINs 3 to 8) as specified in this contract. CLIN 9 was added immediately following the first delivery to provide funding to the contractor for distribution of USG-procured product held in VMI in the event of the small-scale anthrax outbreak. The Contractor must complete specific tasks required in each of the discrete work segments. The scope of work has been broken into the following phases which are discrete work segments:

	
 
	
1.
	
CLIN 1: LATE-STAGE DEVELOPMENT TO SUPPORT LICENSURE OF ANTIBIOTIC (ANTHRAX)

	
 
	
2.
	
CLIN 2: INITIAL PURCHASE, STORAGE AND DELIVERY OF ANTIBIOTIC AS FINAL DRUG PRODUCT (FDP)

	
 
	
3.
	
CLIN 3: SUPPLEMENTAL DEVELOPMENT TO SUPPORT EUA OR LICENSURE OF TREATMENT and/or PEP OF ANTHRAX

	
 
	
4.
	
CLIN 4: BARDA SECURITY REQUIREMENTS, ON-SHORING COMMERCIAL MANUFACTURING [***]

Page 1 of 11

108922677_14

 

	
 
	
5.
	
CLIN 5: POST-MARKETING STUDY COMMITMENTS/ REQUIREMENTS FOR COMMERCIAL CABP AND ABSSSI INDICATIONS

	
 
	
6.
	
CLIN 6: ADDITIONAL PROCUREMENT OF ANTIBIOTIC(S) AS FINAL DRUG PRODUCT (FDP)

	
 
	
7.
	
CLIN 7: ADDITIONAL PROCUREMENT OF ANTIBIOTIC(S) AS FINAL DRUG PRODUCT (FDP)

	
 
	
8.
	
CLIN 8: ADDITIONAL PROCUREMENT OF ANTIBIOTIC(S) AS FINAL DRUG PRODUCT (FDP)

	
 
	
9.
	
CLIN 9: EMERGENCY DISTRIBUTION OF THE PROCURED ANTIBIOTIC

	
1.
	
CLIN 1: LATE-STAGE DEVELOPMENT TO SUPPORT LICENSURE OF ANTIBIOTIC (ANTHRAX)

The Contractor will continue to develop of NUZYRA® for the treatment of pulmonary Anthrax with the objective of obtaining approval through the FDA Animal Rule.

[***]

	
2.
	
CLIN 2: INITIAL PURCHASE, STORAGE AND DELIVERY OF ANTIBIOTIC AS FINAL DRUG PRODUCT (FDP)

The Contractor will supply 2,500 drug product treatment courses of NUZYRA® [***]

[***]

	
3.
	
CLIN 3: SUPPLEMENTAL DEVELOPMENT TO SUPPORT EUA OR LICENSURE OF TREATMENT AND/OR PEP OF ANTHRAX

[***]

	
4.
	
CLIN 4: BARDA SECURITY REQUIREMENTS, ON-SHORING MANUFACTURING, [***]

[***]

	
5.
	
CLIN 5: POST-MARKETING STUDY COMMITMENTS/ REQUIREMENTS FOR COMMERCIAL CABP AND ABSSSI INDICATIONS

[***]

	
6.
	
CLIN 6: ADDITIONAL PROCUREMENT OF ANTIBIOTIC(S) AS FINAL DRUG PRODUCT (FDP)

The Contractor shall store and maintain under the recommended storage conditions purchased NUZYRA® drug product inventory for the US Government in a VMI or deliver such inventory to the ASPR[***] in the manner described in CLIN 2.

	
7.
	
CLIN 7: ADDITIONAL PROCUREMENT OF ANTIBIOTIC(S) AS FINAL DRUG PRODUCT (FDP)

The Contractor shall store and maintain under the recommended storage conditions purchased NUZYRA® drug product inventory for the US Government in a VMI or deliver such inventory to the ASPR[***] in the manner described in CLIN 2.

Page 2 of 11

108922677_14

 

	
8.
	
CLIN 8: ADDITIONAL PROCUREMENT OF ANTIBIOTIC(S) AS FINAL DRUG PRODUCT (FDP)

The Contractor shall store and maintain under the recommended storage conditions purchased NUZYRA® drug product inventory for the US Government in a VMI or deliver such inventory to the ASPR[***] in the manner described in CLIN 2.

	
9.
	
CLIN 9: EMERGENCY DISTRIBUTION OF PROCURED ANTIBIOTIC

The Contractor is to be prepared to deploy up to [***] treatment courses of drug product from existing product in VMI to the field in the United States in the event of a national emergency or an emergency situation under an appropriate regulatory mechanism (e.g., EUA, IND or sNDA), following the agreed upon procedures between Contractor, BARDA[***]

 

Page 3 of 11

108922677_14

 

 

Revised Timeline view of all active CLINs provided in the SOW (09/09/2021)

[***]

 

 

Page 8 of 11

108922677_14

 

 

					
	
WBS
	
Milestone
	
Deliverable
	
Success Criteria
	
Go/No-Go

	
CLIN 001:LATE STAGE DEVELOPMENT TO SUPPORT LICENSURE OF ANTIBIOTIC (ANTHRAX) 
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
 
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
CLIN 002:INITIAL PURCHASE of NUZYRA (VMI) 
Trigger: Pre-EUA FDA Comment (WBS 2.1)

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
CLIN 003:SUPPLEMENTAL DEVELOPMENT FOR Treatment and/or PEP for ANTHRAX 
Trigger: Execution of Contract Modification P00003

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
CLIN 004:BARDA SECURITY REQUIREMENTS, ON-SHORING [***] 
[***]

	
[***]

 

[***]
	
[***]

 

[***]
	
[***]

 

[***]
	
[***]

[***]
	
[***]

[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
CLIN 005:POST-MARKETING STUDY COMMITMENTS/ REQUIREMENTS
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

Page 9 of 11

108922677_14

 

					
	
WBS
	
Milestone
	
Deliverable
	
Success Criteria
	
Go/No-Go

	
CLIN 006: ADDITIONAL PROCUREMENT OF ANTIBIOTIC(S) AS FINAL DRUG PRODUCT (FDP)
Trigger: BARDA receipt of positive top line dose response data from non-GLP dose range-finding study for treatment of inhalation anthrax in rabbits

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
CLIN 007:ADDITIONAL PROCUREMENT OF ANTIBIOTIC(S) AS FINAL DRUG PRODUCT (FDP) 
Trigger: BARDA receipt of positive top line dose response data from non-GLP dose range-finding studies for PEP and treatment of inhalation anthrax in NHPs and positive top line data from pivotal PEP and treatment efficacy studies of inhalation anthrax in rabbits

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
CLIN 008: ADDITIONAL PROCUREMENT OF ANTIBIOTIC(S) AS FINAL DRUG PRODUCT (FDP) 
Trigger: Paratek receives sNDA approval for treatment of inhalational anthrax

	
[***]
	
[***]
	
[***] 
	
[***]
	
[***]

	
CLIN 009:EMERGENCY DISTRIBUTION OF PROCURED ANTIBIOTIC
Trigger: Emergency Request from BARDA/USG

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

 

Page 10 of 11

108922677_14reta-ex101_203.htm

Exhibit 10.1

 

AMENDMENT NO. 2 TO 2004 LICENSE AGREEMENT

 

Amendment No. 2, dated as of August 17, 2021 (this “Amendment”), to the Exclusive Patent License Agreement, dated as of July 15, 2004, as amended by the Amendment effective as of April 11, 2007 and as further amended by the Amendment No. 1 to 2004 License Agreement dated as of July 9, 2012 (as so amended, excluding this Amendment, the “License Agreement”), by and among the Board of Regents (the “BOARD”) of The University of Texas System (the “SYSTEM”), an agency of the State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, on behalf of The University of Texas M. D. Anderson Cancer Center (“UTMDACC”), a component institution of the SYSTEM, Trustees of Dartmouth College (“DARTMOUTH”), a non-profit educational and research institution existing under the laws of the State of New Hampshire, and being located at Hanover, New Hampshire (BOARD, UTMDACC and DARTMOUTH collectively “LICENSORS”), and Reata Pharmaceuticals, Inc., a Delaware corporation and also formerly known as Reata Discovery, Inc. (“REATA”), having a principal place of business located at 5320 Legacy Drive, Plano, Texas 75024.

 

WHEREAS, as part of a corporate reorganization (the “Transaction”), REATA anticipates assigning certain intellectual property rights and agreements, including the License Agreement (the “Assignment”), to its wholly-owned subsidiary, [***] (“Reata Sub”), pursuant to a Contribution Agreement (hereinafter defined).  Upon the closing of the Transaction, Reata Sub will assume all obligations of REATA under the License Agreement arising from and after the closing of the Transaction.  However, REATA will remain liable for and guarantee all obligations under the License Agreement assumed by Reata Sub.

 

WHEREAS, prior to the Assignment, REATA has sublicensed its rights under the License Agreement (pursuant to Section 4.2 thereof) to [***] (“[***] Sub”), a newly-formed indirect wholly-owned subsidiary of REATA (the agreement giving effect to such sublicense, the “Sublicense”).  REATA has also licensed its rights to omaveloxolone to [***] Sub pursuant to an amended and restated license agreement (such license agreement, together with the Sublicense, being referred to herein collectively as the “Sublicenses”). The Sublicenses will be assigned from REATA to Reata Sub as part of the Assignment.

 

WHEREAS, under the License Agreement, DARTMOUTH’s consent and UTMDACC’s consent are required for REATA to assign the License Agreement to Reata Sub.

 

WHEREAS, DARTMOUTH desires to monetize (a “Monetization”) all or a portion of its rights to receive running royalties under Section 5.1(c) and Article 17 of the License Agreement and payments related thereto (including, without limitation, as distributed to DARTMOUTH pursuant to the Amended and Restated Commercialization Agreement between UTMDACC and DARTMOUTH, dated October 6, 2000) (collectively, the “Receivables”), including by means of an assignment of such Receivables, and such a Monetization may take the form of a direct sale, a loan or otherwise.

 

 

 
WHEREAS, each of DARTMOUTH and UTMDACC agrees to consent to the assignment of the License Agreement as amended by this Amendment (the “Amended License Agreement”)

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
1
 

 

by REATA to Reata Sub on the terms and conditions specified in this Amendment and in the Amended License Agreement.

 

WHEREAS, the parties now wish to amend the License Agreement to, among other things, (i) reflect the Assignment, (ii) include a guarantee granted by REATA of the obligations of Reata Sub under the Amended License Agreement, (iii) amend the definition of NET SALES, (iv) provide that all reports (including, without limitation, royalty reports) and correspondence to be delivered by the LICENSEE (as defined below) to UTMDACC in connection with the License Agreement are to also be concurrently delivered by the LICENSEE (as defined below) directly to DARTMOUTH, (iv) revise the confidentiality provisions of the License Agreement to permit the disclosure of certain information in connection with a Monetization, (v) specify the resolution procedure in respect of the Article 17 Matter (as defined below) and (vi) clarify the applicability of certain running royalty payment obligations with respect to certain compounds, in each case on the terms and conditions specified in this Amendment and in the Amended License Agreement.

 

NOW, THEREFORE, in consideration of the recitals above and the mutual promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, do hereby agree as follows:

 

1.Definitions.  Capitalized terms used in this Amendment and not otherwise defined herein shall have the meanings ascribed to such terms in the Amended License Agreement.

 

2.Consent to Assignment.  Each of DARTMOUTH and UTMDACC hereby consents, under Article 10 of the Amended License Agreement, to the assignment of the Amended License Agreement by REATA to Reata Sub.  REATA shall ensure that, on the effective date of the Contribution Agreement, Reata Sub assumes all obligations of REATA under the Amended License Agreement (other than those set forth in Article 22 of the Amended License Agreement) arising from and after the closing of the Transaction. REATA hereby agrees to (i) remain liable for and guarantee all obligations under the Amended License Agreement assumed by Reata Sub and (ii) on the effective date of the Contribution Agreement, deliver to DARTMOUTH and UTMDACC a contribution agreement duly executed by REATA and Reata Sub that is in the form of the contribution agreement attached hereto as Exhibit 1 (the “Contribution Agreement”). 

 

3.Amendment to LICENSEE Definition.  With effect from and after the effective date of the Contribution Agreement, the definition of the term “LICENSEE” in the preamble of the License Agreement is hereby amended and restated in its entirety as follows:

 

“[***] (“LICENSEE”), a Delaware limited liability company having a principal place of business located at 5320 Legacy Drive, Plano, Texas 75024.”

 

4.REATA Guaranty.  With effect from and after the effective date of the Contribution Agreement, the following new Article 22 is hereby added to the License Agreement: 

 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
2
 

 

 

 

“22.  GUARANTY

 

22.1    The Guaranty.  

(a)         Reata Pharmaceuticals, Inc. (“GUARANTOR”) hereby unconditionally guarantees the full and punctual payment (upon demand or otherwise) of all of the payment obligations of LICENSEE payable under this AGREEMENT (the “PAYMENT OBLIGATIONS”).  Upon failure by LICENSEE to pay punctually any such PAYMENT OBLIGATION, GUARANTOR shall forthwith on demand pay the amount not so paid at the place and in the manner and the currency specified in this AGREEMENT (it being understood and agreed that any disputes with respect to the amount of any PAYMENT OBLIGATION owed under Section 5.1(c) or Article 17 will be addressed with the LICENSEE in accordance with Article 18 prior to any claim being made against the GUARANTOR pursuant to this Article 22 with respect to such amount).

(b)         GUARANTOR hereby unconditionally guarantees the full and punctual performance (upon demand or otherwise) of all other obligations of LICENSEE under this AGREEMENT (the “PERFORMANCE OBLIGATIONS” and together with the PAYMENT OBLIGATIONS, the “LICENSEE OBLIGATIONS”).  Upon failure by LICENSEE to perform punctually any such PERFORMANCE OBLIGATION, GUARANTOR shall forthwith on demand perform such PERFORMANCE OBLIGATION in the manner specified in this AGREEMENT.

22.2    Guaranty Unconditional.  The obligations of GUARANTOR under this Article 22 shall be unconditional and absolute and, without limiting the generality of the foregoing, shall not be released, discharged or otherwise affected by:

(a)        any extension, renewal, settlement, compromise, waiver or release in respect of any LICENSEE OBLIGATION, by operation of law or otherwise; provided, however, that the release by LICENSORS in writing of LICENSEE in respect of any LICENSEE OBLIGATION under this AGREEMENT shall also operate to release GUARANTOR from its obligations hereunder in respect of such LICENSEE OBLIGATION;

(b)         any modification or amendment of or supplement to this AGREEMENT or any other document referred to herein; provided, however, that the release by LICENSORS in writing of LICENSEE in respect of any LICENSEE OBLIGATION under this AGREEMENT shall also operate to release GUARANTOR from its obligations hereunder in respect of such LICENSEE OBLIGATION;

(c)         any change in the existence, structure or ownership of LICENSEE, or any insolvency, bankruptcy, reorganization or other similar proceeding affecting LICENSEE or its assets or any resulting release or discharge of any LICENSEE OBLIGATION;

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
3
 

 

(d)         the existence of any claim, set-off or other rights which GUARANTOR may have at any time against LICENSEE, any LICENSOR or any other corporation, entity or person, whether in connection herewith or any unrelated transaction, provided that nothing herein shall prevent the assertion of any such claim by separate suit or compulsory counterclaim;

(e)         any invalidity or unenforceability relating to or against LICENSEE for any reason of this AGREEMENT, or any provision of applicable law or regulation purporting to prohibit the payment by LICENSEE of any PAYMENT OBLIGATION or the performance by LICENSEE of any of its other LICENSEE OBLIGATIONS under this AGREEMENT; or

(f)          any other act or omission to act or delay of any kind by LICENSEE, any LICENSOR or any other corporation, entity or person or any other circumstance whatsoever which might, but for the provisions of this paragraph, constitute a legal or equitable discharge of GUARANTOR’s obligations hereunder.

22.3    Discharge Only Upon Payment in Full; Reinstatement In Certain Circumstances.  GUARANTOR’s obligations under Section 22.1 shall remain in full force and effect until all LICENSEE OBLIGATIONS have been irrevocably and unconditionally satisfied and paid in full.  If at any time any payment made of any LICENSEE OBLIGATION is rescinded or must be otherwise restored or returned upon the insolvency, bankruptcy or reorganization of LICENSEE or otherwise, GUARANTOR’s obligations hereunder with respect to such payment shall be reinstated as though such payment had been due but not made at such time.

22.4    Waiver by GUARANTOR.  GUARANTOR irrevocably waives acceptance hereof, presentment, demand, protest and any notice not expressly provided for herein, as well as any requirement that at any time any action be taken by any LICENSOR or any other corporation, entity or person against LICENSEE or any other corporation, entity or person.

22.5        Subrogation.  Upon making any payment hereunder with respect to LICENSEE, GUARANTOR shall be subrogated to the rights of LICENSORS against LICENSEE with respect to such payment; provided that GUARANTOR shall not enforce any payment right by way of subrogation until all LICENSEE OBLIGATIONS have been paid in full.

 

22.6   Confirmation by GUARANTOR. GUARANTOR confirms, acknowledges and agrees that the provisions of this Article 22 constitute obligations of GUARANTOR (and have not been, and will not be, assigned to, or assumed by, LICENSEE pursuant to the Contribution Agreement referred to in Section 2 of Amendment No. 2 to this AGREEMENT).”

 

5.Other Amendments.  With effect from and after the date hereof, the License Agreement is hereby amended as follows:

 

(a)Section 2.10 of the License Agreement is hereby amended and restated in its entirety as follows: 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
4
 

 

 

“2.10  NET SALES means, with respect to a LICENSED PRODUCT for any period in any country, the total amount billed or invoiced on sales of such LICENSED PRODUCT during such period by LICENSEE or its AFFILIATES or its or their Sublicensees/Distributors in such country to third parties (including wholesalers or distributors who are not Sublicensees/Distributors) in bona fide arm’s length transactions, less the following deductions, in each case to the extent such deductions relate specifically to such LICENSED PRODUCT in such country and are actually allowed and taken by such third parties and are not otherwise recovered by or reimbursed to LICENSEE or its AFFILIATES or its or their Sublicensees/Distributors:  

(a)trade, cash and quantity discounts;

(b)price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities; 

(c)taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced;

(d)freight, insurance, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such LICENSED PRODUCT;

(e)amounts repaid or credited by reason of rejections, defects, one percent (1%) return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs; and

(f)any invoiced amounts from a prior period that are written off or reserved as not collectable by LICENSEE or its AFFILIATES or its or their Sublicensees/Distributors, including bad debts.

NET SALES shall include the amount or fair market value of all other consideration received by LICENSEE or its AFFILIATES or its or their Sublicensees/Distributors in respect of such LICENSED PRODUCT, whether such consideration is in cash, payment in kind, exchange, or other form.  NET SALES shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes so long as such transfer or disposition is made at or below  cost.  NET SALES shall not include sales between or among LICENSEE or its Affiliates or its or their Sublicensees/Distributors so long as such AFFILIATES or Sublicensees/Distributors are not end-users of such LICENSED PRODUCT.  Subject to the above, NET SALES shall be calculated in accordance with the standard internal policies and procedures of LICENSEE or its AFFILIATES or its or their Sublicensees/Distributors, which must be in accordance with GAAP and consistently applied.  

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
5
 

 

i.If a LICENSED PRODUCT is sold as a Combination Product for any period in any country, the NET SALES for such Combination Product will be calculated as follows: If LICENSEE, its AFFILIATES, or Sublicensees/Distributors separately sells in such country, (x) LICENSED PRODUCTS containing as its sole active ingredient the compound which is covered by or is produced using LICENSED SUBJECT MATTER contained in such Combination Product (the “Mono Product”) and (y) products containing as their sole active ingredients the other active ingredient(s) in such Combination Product, the NET SALES attributable to such Combination Product shall be calculated by multiplying actual NET SALES of such Combination Product by the fraction A/(A+B) where: A is LICENSEE’s (or its AFFILIATE’s or Sublicensees/Distributor’s, as applicable) average NET SALES price during the period to which the NET SALES calculation applies for the Mono Product(s) in such country and B is LICENSEE’s (or its AFFILIATE’s or Sublicensees/Distributor’s, as applicable) average NET SALES price during the period to which the NET SALES calculation applies in such country, for products that contain as their sole active ingredient(s) the other active ingredient(s) in such Combination Product.

ii.If LICENSEE, its AFFILIATES, or Sublicensees/Distributors separately sells in such country the Mono Product but does not separately sell in such country products containing as their sole active ingredient(s) the other active ingredient(s) in such Combination Product, the NET SALES attributable to such Combination Product shall be calculated by multiplying the NET SALES of such Combination Product by the fraction A/C where: A is LICENSEE’s (or its AFFILIATE’s or Sublicensees/Distributor’s, as applicable)  average NET SALES price during the period to which the NET SALES calculation applies for the Mono Product in such country, and C is LICENSEE’s (or its AFFILIATE’s or Sublicensees/Distributor’s, as applicable) average NET SALES price in such country during the period to which the NET SALES calculation applies for such Combination Product.

iii.If LICENSEE, its AFFILIATES, or Sublicensees/Distributors do not separately sell in such country the Mono Product but do separately sell products containing as their sole active ingredient(s) the other active ingredient(s) contained in such Combination Product, the NET SALES attributable to such Combination Product shall be calculated by multiplying the NET SALES of such Combination Product by the fraction (D-E)/D where: D is the average NET SALES price during the period to which the NET SALES calculation applies for such Combination Product in such country and E is the average NET SALES price during the period to which the NET SALES calculation applies for products that contain as their sole active ingredient(s) the other active ingredient(s) in such Combination Product.

iv.If LICENSEE, its AFFILIATES, or Sublicensees/Distributors do not separately sell in such country both the Mono Product and the other active ingredient or ingredients in such Combination Product, the NET SALES attributable to such Combination Product shall be determined by the PARTIES in 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
6
 

 

good faith based on the relative fair market value of such Mono Product and such other active ingredient or ingredients.

As used herein, “Sublicensee/Distributor” means (a) a sublicensee or (b) a third party who is not a sublicensee, but to whom LICENSEE or any of its AFFILIATES has granted the right to distribute LICENSED PRODUCTS wherein such third party makes payments to LICENSEE or any of its AFFILIATES for the right to sell (or resell) LICENSED PRODUCTS, whether or not such payment is in the form of a royalty (or other amount) based upon the revenues received by such third party for the sale (or resale) of such LICENSED PRODUCTS.  For clarity, the following entities are not Sublicensee/Distributors under the foregoing clause (b): (i) McKesson Corporation, AmerisourceBergen, Cardinal Health and Besse Medical, in each case based on the activities performed by those entities as of the date of Amendment No. 2 to this AGREEMENT, and other entities performing like activities in other countries in the Territory; and (ii) any other third party that acts as a wholesaler or provides warehousing or logistical support with respect to the sale or distribution of LICENSED PRODUCTS, without more.

 

As used herein, “Combination Product” means a LICENSED PRODUCT that comprises or contains both (1) a compound which is covered by or is produced using LICENSED SUBJECT MATTER as an active pharmaceutical ingredient; plus (2) one or more other active pharmaceutical ingredients that is not described in the foregoing clause (1), and that is sold either as a fixed dose or as separate doses in a single package for a single price.”

 

(b)In Sections 4.3, 5.1(c), 5.4, 5.5 and 12.3 of the License Agreement, (i) each reference to “sublicensee” is hereby replaced with a reference to “Sublicensee/Distributor”, (ii) each reference to “sublicensees” is hereby replaced with a reference to “Sublicensees/Distributors”, (iii) each reference to “sublicensee’s” is hereby replaced with a reference to “Sublicensee’s/Distributor’s, (iv) each reference to “ sublicensees’ ” is hereby replaced with a reference to “ Sublicensees’/Distributors’ ” and (v) each reference to “sublicensee(s)” is hereby replaced with a reference to “Sublicensees/Distributors”.

 

(c)In Exhibit 2 to the License Agreement, the reference to “Sublicensees” is hereby replaced with a reference to “Sublicensees/Distributors”.

 

(d)Section 5.5 of the License Agreement is hereby amended by deleting the reference to “30 days” in the first sentence of such Section 5.5 and replacing it with a reference to “60 days”.

 

(e)Article 10 of the License Agreement is hereby amended by adding the following to the end of such Article 10:

 

“Notwithstanding any provision of this AGREEMENT to the contrary, each LICENSOR shall have the right to assign, convey, sell or otherwise transfer all or any portion of its rights, interests and obligations under this AGREEMENT to any other LICENSOR at any time, including, without limitation, any PATENT RIGHTS and the rights to receive payments pursuant to Articles 5, 9, 17, 18 and 22 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
7
 

 

of this AGREEMENT.  In the event of any such assignment, conveyance or other transfer of such rights, interests or obligations, each LICENSOR agrees to provide notice thereof to LICENSEE promptly following the execution of any agreements reflecting the same, as well as a description of each right, interest or obligation thereby assigned, conveyed, sold or otherwise transferred.”

 

(f)Article 14 of the License Agreement is hereby amended by adding the following new Section 14.5 to the end of such Article 14:

 

“14.5Notwithstanding anything in this AGREEMENT to the contrary, the PARTIES acknowledge and agree that:

 

(a)(i) DARTMOUTH may monetize (a “Monetization”) all or a portion of its rights to receive running royalties under Section 5.1(c) and Article 17 hereof and payments related thereto (including, without limitation, as distributed to DARTMOUTH pursuant to the Commercialization Agreement) (collectively, the “Receivables”), including by means of an assignment of such Receivables, and (ii) such a Monetization may take the form of a direct sale (through an auction process or otherwise) or a financing (through a borrowing of loans or otherwise), it being understood and agreed, for the avoidance of doubt, that nothing in this Section 14.5 shall be construed to require UTMDACC or LICENSEE to incur any obligations in connection with a Monetization other than as otherwise set forth in this AGREEMENT or the Commercialization Agreement; and

 

(b)in connection with a Monetization, DARTMOUTH may provide interested parties and the actual purchaser in such Monetization on an ongoing basis with copies of (i) the Relevant Agreements (as defined below), (ii) the royalty reports provided under the Relevant Agreements, and (iii) notices, reports and correspondence given or received under the Relevant Agreements; provided, however, that prior to disclosing any of the foregoing, each such interested party and actual purchaser shall execute a customary confidentiality agreement with DARTMOUTH covering such information.  “Relevant Agreements” means, collectively, (A) this AGREEMENT, the Commercialization Agreement, the Settlement Agreement, the Contribution Agreement (as defined in Section 2 of Amendment No. 2 to this AGREEMENT) and the Sublicenses (as defined in the second Whereas clause of Amendment No. 2 to this AGREEMENT), (B) any agreements required to be provided by UTMDACC to DARTMOUTH, or by LICENSEE to UTMDACC or DARTMOUTH, under any of the agreements referenced in the immediately preceding clause (A), and (C) all amendments and other modifications to the agreements referenced in the immediately preceding clauses (A) and (B).”

 

(g)The following new Article 20 is hereby added to the License Agreement:

 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
8
 

 

 

	
 
	
“20.
	
ROYALTY PAYMENTS RELATED TO Bardoxolone and Omaveloxolone

 

20.1“BARDOXOLONE” means that compound having the chemical structure set forth below:

 

20.2“OMAVELOXOLONE” means that compound having the chemical structure set forth below:

 

 

 

20.3Notwithstanding anything to the contrary in this AGREEMENT, LICENSEE, DARTMOUTH and UTMDACC acknowledge and agree that:

 

(a)BARDOXOLONE is LICENSED SUBJECT MATTER (as defined in Section 2.8) because it is an invention, discovery or process covered by PATENT RIGHTS and/or TECHNOLOGY RIGHTS within LICENSED FIELD.  As such, a world-wide running royalty of [***] percent ([***]%) of NET SALES of any product, process or service which is covered by or is produced using BARDOXOLONE (“BARDOXOLONE PRODUCT”) shall, on a country-by-country and product-by-product basis, be payable by LICENSEE pursuant to Section 5.1(c) hereof on NET SALES of any BARDOXOLONE PRODUCT in any particular country until the expiration of the last-to-expire of the PATENT RIGHTS that Covers such BARDOXOLONE PRODUCT in such country.  The dispute (which remains unresolved as of the date of Amendment No. 2 to this AGREEMENT) between the LICENSEE and the LICENSORS regarding whether BARDOXOLONE PRODUCTS are also products on which the [***] percent ([***]%) world-wide running royalty under Article 17 is payable (such dispute, the “Article 17 Matter”) shall be resolved in accordance with the provisions of Section 16.6.  The PARTIES hereby agree to initiate mediation under Section 16.6 regarding the Article 17 Matter within [***] ([***]) days after the first date on 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
9
 

 

which the FDA approves the sale and marketing of a BARDOXOLONE PRODUCT.  Nothing in Amendment No. 2 to this AGREEMENT shall be considered, referenced or introduced into evidence in connection with the Article 17 Matter or the resolution thereof.  The PARTIES’ agreement and understanding that BARDOXOLONE is LICENSED SUBJECT MATTER as defined in Section 2.8 and that a [***] percent ([***]%) world-wide running royalty under Section 5.1(c) is payable with respect to NET SALES of BARDOXOLONE PRODUCTS (as further described in the first and second sentences of this clause (a)) shall not in any way be affected by (i) the existence of the Article 17 Matter, (ii) the manner in which the Article 17 Matter is resolved (or in which it remains unresolved) or (iii) the terms and conditions of any resolution of the Article 17 Matter.

 

(b)OMAVELOXOLONE is not LICENSED SUBJECT MATTER as defined in Section 2.8, and the OMAVELOXOLONE PATENTS (as defined in Schedule A to Amendment No. 2 to this AGREEMENT) Cover any products that contain or embody OMAVELOXOLONE (such products, “OMAVELOXOLONE PRODUCTS”). OMAVELOXOLONE PRODUCTS are products on which the [***] percent ([***]%) world-wide running royalty under Article 17 is payable.  As such, a world-wide running royalty of [***] percent ([***]%) of NET SALES of each OMAVELOXOLONE PRODUCT shall, on a country-by-country and product-by-product basis, be payable by LICENSEE pursuant to Article 17 hereof on NET SALES of any OMAVELOXOLONE PRODUCT in any particular country until the expiration of the last-to-expire of the OMAVELOXOLONE PATENTS (as defined in Schedule A to Amendment No. 2 to this AGREEMENT) that Covers such OMAVELOXOLONE PRODUCT in such country.

 

(c)  As used herein, “Covers” means, with respect to a patent and a product, that such patent would (absent a license thereunder and/or ownership thereof) be infringed by the making, manufacture, use, importation, offer for sale or sale of such product in the applicable country.”  

 

(h)The following new Article 21 is hereby added to the License Agreement:

 

	
 
	
“21.
	
DOCUMENT DELIVERY TO DARTMOUTH

 

Notwithstanding any provisions of this Agreement to the contrary, LICENSEE shall deliver all notices, reports, statements and other documents under this Agreement (including, without limitation, all royalty reports under Section 5.5 and Article 17 hereof) concurrently to both UTMDACC and DARTMOUTH by email (with PDF attachment) to (i) in the case of UTMDACC, fprat@mdanderson.org (or such other email address as may be designated from time to time by UTMDACC to LICENSEE) and (ii) in the case of DARTMOUTH, kim.e.rosenfield@dartmouth.edu (or such other email address as may be designated from time to time by DARTMOUTH to LICENSEE).”

 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
10
 

 

 

(i)Section 8.4(b) of the License Agreement is hereby amended and restated in its entirety as follows: 

 

“b.Without limiting the provisions of this Section 8.4 and notwithstanding anything herein to the contrary, each PARTY, as applicable, agrees and covenants to be bound by the provisions of Section 8.4, Article 12 (Indemnification), Article 13 (Use of Name), Article 14 (Confidential Information), Article 16 (General), Article 17 (Collaboration Agreement Fee), Article 18 (Royalty Dispute Resolution), Article 20 (Royalty Payments Related to Bardoxolone and Omaveloxolone) and Article 22 (Guaranty) and all definitions contained, and other Sections and all Exhibits cross-referenced, therein;”

 

6.Effect of Amendment.  Except as amended by this Amendment, the License Agreement shall remain in full force and effect pursuant to its terms.  By signing this Amendment, each of the parties hereto hereby agrees that the Amended License Agreement is hereby ratified and affirmed in all respects.  Each reference in the Amended License Agreement to “this Agreement”, “herein”, “hereunder” or words of similar import shall mean and be a reference to (a) from and after the date hereof, the License Agreement as amended by Section 5 of this Amendment and (b) from and after the effective date of the Contribution Agreement, the License Agreement as amended by Sections 3, 4 and 5 of this Amendment.

 

7.Governing Law.  This Amendment will be construed and enforced in accordance with the laws of the United States of America and of the State of Texas, without regard to its conflict of law provisions.

 

8.Counterparts.  This Amendment may be executed in one or more counterparts all of which together shall constitute one and the same agreement.  The delivery by any party of an executed counterpart hereof by facsimile transmission or email of .pdf copies shall be effective as an original executed counterpart of this Amendment by such party and shall constitute an original enforceable document.

 

[signatures set forth on the following page]

 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
11
 

 

 

IN WITNESS WHEREOF, the parties have duly executed this Amendment as of the date first written above.

 

REATA PHARMACEUTICALS, INC.

 

 

By: /s/ Manmeet S. Soni _______________

Name: Manmeet S. Soni

Title:   Chief Operating Officer, Chief Financial Officer and Executive Vice President 

 

 

 

TRUSTEES OF DARTMOUTH COLLEGE

 

 

By: /s/_ Kim E. Rosenfield _____________

Name: Kim E. Rosenfield

Title: Director, Technology Transfer

 

 

 

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

THE UNIVERSITY OF TEXAS M.D. ANDERSON CANCER CENTER

 

 

By: /s/_ Ben Melson________________

Name: Ben Melson

Title: SVP, CFO

 

 

[Signature Page to Amendment No. 2 to 2004 License Agreement]

 

 

 

Schedule A

Omaveloxolone Patents

 

 

[***] 

					
	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

	
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[***]
	
[***]

	
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[***]
	
[***]
	
[***]
	
[***]

	
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[***]
	
[***]
	
[***
	
[***]

	
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[***]
	
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[***]

	
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[***]

	
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[***]

	
[***]
	
[***]
	
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[***]

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
 

 

					
	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]

 
	
[***]
	
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[***]
	
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[***] 

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]

 
	
[***]
	
[***]
	
[***]

 

 

 

 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 
 

 

 

Exhibit 1

 

Contribution Agreement

 

 

[***]

 

 

Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].

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