UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 22, 2019

 

Reata Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

DELAWARE

001-37785

11-3651945

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

2801 Gateway Drive; Suite 150

Irving, TX 75063

(Address of Principal executive offices, including zip code)

(972) 865-2219

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Class A Common Stock, Par Value $0.001 Per Share

 

RETA

 

NASDAQ Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 


 

Item 1.01.Entry into a Material Definitive Agreement.

Fifth and Sixth Supplements to Exclusive License and Supply Agreement

 

On December 24, 2009, Reata Pharmaceuticals, Inc. (the “Company”) entered into the Exclusive License and Supply Agreement (the “Original License Agreement”) by and between the Company and Kyowa Kirin Co., Ltd., formerly known as Kyowa Hakko Kirin Co., Ltd. (“KKC”), under which the Company provided KKC the right to develop and commercialize bardoxolone methyl for renal, metabolic, and cardiovascular indications in Japan, China (including Hong Kong and Macao), South Korea, Taiwan, Thailand, Singapore, Philippines, Malaysia, Indonesia, Brunei, Vietnam, Laos, Myanmar, and Cambodia.  

On August 22, 2019, the Company entered into the Fifth Supplement to Exclusive License and Supply Agreement (the “Fifth Supplement”), by and between the Company and KKC. The Fifth Supplement further amends the Original License Agreement by revising various pricing terms and payments between the parties.

On August 22, 2019, the Company entered into the Sixth Supplement to Exclusive License and Supply Agreement (the “Sixth Supplement”), by and between the Company and KKC.  The Sixth Supplement sets forth the parties respective obligations and responsibilities with respect to the conduct of a portion of a phase 3 clinical trial of bardoxolone methyl (RTA 402) for the indication of autosomal dominant polycystic kidney disease in Japan.

The foregoing descriptions of the Original License Agreement, the Fifth Supplement, and the Sixth Supplement are qualified in their entirety by reference to the full text of the Original License Agreement, the Fifth Supplement, and the Sixth Supplement, as applicable. The Original License Agreement is attached as Exhibit 10.15 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. The Fifth Supplement and the Sixth Supplement are attached as Exhibit 10.1 and Exhibit 10.2 to this Current Report on Form 8-K and incorporated in this Item 1.01 by reference.

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Item 9.01.Financial Statements and Exhibits.

(d)Exhibits

Exhibit No.

  

Description

 

 

10.1*

  

Fifth Supplement to Exclusive License and Supply Agreement, dated August 22, 2019, between Reata Pharmaceuticals, Inc. and Kyowa Kirin Co., Ltd.

 

 

10.2*

  

Sixth Supplement to Exclusive License and Supply Agreement, dated August 22, 2019, between Reata Pharmaceuticals, Inc. and Kyowa Kirin Co., Ltd.

 

 

 

 

 

* Confidential information has been omitted from this Exhibit pursuant to Securities and Exchange Commission regulations.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

Reata Pharmaceuticals, Inc.

 

 

 

 

Date: August 22, 2019

 

By:

/s/ J. Warren Huff

 

 

 

J. Warren Huff

 

 

 

Chief Executive Officer

 

 

4

Exhibit 10.1

 

FIFTH SUPPLEMENT TO EXCLUSIVE LICENSE AND SUPPLY AGREEMENT

Regarding Milestone payments

This Fifth Supplement (herein so called), effective as of August 22, 2019 (the “Supplement Effective Date”), to the Exclusive License and Supply Agreement, effective as of December 24, 2009 (the “Original Agreement”), is by and between Reata Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, USA, with an address at 2801 Gateway Drive, Suite 150, Irving, Texas 75063 (“Reata”), and Kyowa Kirin Co., Ltd., a company organized and existing under the laws of Japan, with an address at 1-9-2 Ohtemachi, Chiyoda-ku, Tokyo, 100-0004, Japan (“Kyowa Kirin”). Reata and Kyowa Kirin are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties”.

WHEREAS, pursuant to the Original Agreement, Reata has granted to Kyowa Kirin an exclusive, royalty-bearing license under the Licensed Technology to research, develop, use, sell, offer for sale, import, and export Licensed Compound and Licensed Product in the Field in the Territory.

WHEREAS, the Parties executed the Supplement to the Original Agreement dated January 1, 2016 (“First Supplement”), under which Kyowa Kirin agreed to allow Reata to perform a Phase 3 clinical study of RTA 402 (which is included in the Licensed Compound) in the field of connective tissue disease associated pulmonary arterial hypertension (which is included in the Field) (“CTD-PAH”) in Japan (which is included in the Territory) (“CTD-PAH Study”).

WHEREAS, the Parties executed the Second Supplement to the Original Agreement dated March 21, 2017 (“Second Supplement”), under which Kyowa Kirin agreed to allow Reata to perform portions of CTD-PAH studies in the Philippines (which is included in the Territory).

WHEREAS, the Parties executed the Third Supplement to the Original Agreement dated December 6, 2017 (“Third Supplement”), under which Kyowa Kirin agreed to allow Reata to perform a Phase 3 clinical study of RTA 402 in the field of Alport Syndrome (“AS”) in Japan (“AS Study”) and agreed to bear Reata’s actual development costs incurred in the AS Study up to three million United States dollars (US$3,000,000).

WHEREAS, the Parties executed the Fourth Supplement to the Original Agreement dated December 6, 2017 (“Fourth Supplement”), under which the Parties amended the terms regarding milestone payments, supply price and products manufacturing.

WHEREAS, the Parties wish to amend the terms of the Original Agreement as set forth herein.

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

Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 


1. Milestone payments

1.1  Notwithstanding Section 1.1 of the Fourth Supplement, Section 7.2.1 (Regulatory Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section:

“Notwithstanding the foregoing, if the milestone event of [***] shall be as follows:

i)

[***]

ii)

[***]

iii)

[***]

iv)

[***]

For the avoidance of doubt, [***].

Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***].

The Parties further agree that Kyowa Kirin shall not be obliged to pay Regulatory Milestone Payments for the indications other than [***].”

1.2  Notwithstanding Section 1.2 of the Fourth Supplement, Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section:

“The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US[***]. Notwithstanding the foregoing, [***]shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table.  If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment.

 

 

Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

 

 

 

 

 

2

 


Sales Milestone Event

Sales Milestone Payment (US$)

[***]

$[***]

[***]

$[***]

[***]

$[***]

[***]

$[***]

 

[***]:

Sales Milestone Event

Sales Milestone Payment (US$) set forth in this Section 7.2.2

Unpaid Regulatory Milestone Payment for [***] in total: $[***]

Sales Milestone Payment (US$) for [***]

[***]

$[***]

$[***]

$[***]

[***]

$[***]

$[***]

$[***]

 

[***]

$[***]

$[***]

$[***]

 

[***]

$[***]

$[***]

$[***]

 

 

[***].

 

2.  Other Provisions

2.1   This Fifth Supplement shall become effective as of the Supplement Effective Date and shall continue until the termination of the Original Agreement.

2.2   Except where specifically defined herein, capitalized terms used herein shall have the same meanings ascribed to them in the Original Agreement.

2.3      The headings to the several Articles hereof are not part of this Fifth Supplement, but are merely guides or labels to assist the locating and reading the several Articles hereof.

2.4    Except as stated herein, all terms and conditions of the Original Agreement and all the Supplements to the Original Agreement shall remain in full force and effect during the effective period of the Original Agreement.

 

Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

3

 


IN WITNESS WHEREOF, the Parties have executed this Fifth Supplement to be effective as of the Supplement Effective Date.

 

 

KYOWA KIRIN CO., LTD.

By:

/s/ Yasuo Fujii

 

 

 

 

Name:

Yasuo Fujii

 

 

 

 

Title:

Executive Officer, Director,

 

 

Business Development Department

 

 

 

 

Date:

August 22, 2019

 

 

REATA PHARMACEUTCALS, INC.

By:

/s/ J. Warren Huff

 

 

 

 

Name:

J. Warren Huff

 

 

 

 

Title:

President and Chief Executive Officer,

 

 

 

 

Date:

July 30, 2019

 

 

Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

4

 

Exhibit 10.2

SIXTH SUPPLEMENT TO EXCLUSIVE LICENSE AND SUPPLY AGREEMENT

Regarding Phase 3 Clinical Study (ADPKD) in Japan

This Sixth Supplement (herein so called), effective as of August 22, 2019 (the “Supplement Effective Date”), to the Exclusive License and Supply Agreement, effective as of December 24, 2009 (the “Original Agreement”), is by and between Reata Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, USA, with an address at 2801 Gateway Drive, Suite 150, Irving, Texas 75063 (“Reata”), and Kyowa Kirin Co., Ltd., a company organized and existing under the laws of Japan, with an address at 1-9-2 Ohtemachi, Chiyoda-ku, Tokyo, 100-0004, Japan (“Kyowa Kirin”). Reata and Kyowa Kirin are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties”.

 

WHEREAS, pursuant to the Original Agreement, Reata has granted to Kyowa Kirin an exclusive, royalty-bearing license under the Licensed Technology to research, develop, use, sell, offer for sale, import, and export Licensed Compound and Licensed Product in the Field in the Territory.

WHEREAS, the Parties executed several supplements to the Original Agreement including the Fifth Supplement, under which the Parties amended the terms regarding milestone payments relating to the indication of Autosomal dominant polycystic kidney disease (“ADPKD”).

WHEREAS, Kyowa Kirin wishes to perform portions of a Phase 3 clinical study of RTA 402 (which is included in the Licensed Compound) for the indication of ADPKD (which is included in the Field) in Japan (which is included in the Territory) with a corresponding Protocol Number 402-C-1808 (“Study”) by participating in the global Phase 3 clinical study of RTA 402 for the indication of ADPKD which is planned and conducted by Reata, as a sponsor of the Study.

WHEREAS, in order to clarify and agree on obligation and responsibility of the Parties for the Study, the Parties wish to supplement the terms of the Original Agreement as set forth herein.

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

 

1. Obligation and Responsibility of the Parties

1.1   Kyowa Kirin shall be an in-country (Japan) caretaker of the Study and solely responsible for the conduct thereof. For clarity, relevant provisions including but not limited to the Article IV (CLINICAL DEVELOPMENT) and the Article V (REGULATORY MATTERS) of the Original Agreement shall apply and Kyowa Kirin will conduct the Study in accordance with those provisions. Notwithstanding the forgoing, Kyowa Kirin shall bear the Study costs (the “Costs”) necessary for enrollment of up to [***] patients, and

Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***].

 


 

Reata shall bear any increase in the Costs that are allocable to the excess enrollment above [***] patients if such excess enrollment is based on Reata’s desire despite the fact that it is not required for the Study. Costs shall mean (i) any external costs to be paid by Kyowa Kirin to any third parties for the Study and (ii) any internal costs of Kyowa Kirin for the Study with a FTE rate of JPY [***] million. In case of such excess enrollment, Kyowa Kirin shall invoice Reata each quarter for the Costs, and Reata shall pay each invoice within thirty (30) days from the end of the calendar month in which Reata receives the invoice.

1.2   An agreement with a contract research organization (“CRO”) shall be entered into by and between Reata, Kyowa Kirin and the CRO.

 

2.  Original Agreement

Except as supplemented and amended by this Sixth Supplement, the Original Agreement and all the Supplements to Exclusive License and Supply Agreement between the Parties, shall remain in full force and effect pursuant to their terms
        

3.  Other Provisions

3.1   This Sixth Supplement shall become effective as of the Supplement Effective Date and shall continue until the termination of the Original Agreement.

3.2   Except where specifically defined herein, capitalized terms used herein shall have the same meanings ascribed to them in the Original Agreement.

3.3   The headings to the several Articles hereof are not part of this Sixth Supplement, but are merely guides or labels to assist the locating and reading the several Articles hereof.

3.4   Except as stated herein, all terms and conditions of the Original Agreement and all the Supplements to the Original Agreement shall remain in full force and effect during the effective period of the Original Agreement.

 

 

 

 

 

Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

2

 


 

IN WITNESS WHEREOF, the Parties have executed this Sixth Supplement to be effective as of the Supplement Effective Date.

 

 

KYOWA KIRIN CO., LTD.

By:

/s/ Yasuo Fujii

 

 

 

 

Name:

Yasuo Fujii

 

 

 

 

Title:

Executive Officer, Director,

 

 

Business Development Department

 

 

 

 

Date:

August 22, 2019

 

 

REATA PHARMACEUTCALS, INC.

By:

/s/ J. Warren Huff

 

 

 

 

Name:

J. Warren Huff

 

 

 

 

Title:

President and Chief Executive Officer,

 

 

 

 

Date:

July 30, 2019

 

 

 

 

 

 

Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

3