Document:

arwr-ex1020_311.htm

 

EXHIBIT 10.20

 

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

AMENDMENT NO. 2 TO LICENSE AGREEMENT

 

THIS AMENDMENT NO. 2 TO LICENSE AGREEMENT (this “Second Amendment”) is made and entered into as of February 4, 2019 (the “Second Amendment Effective Date”) and is by and between Arrowhead Pharmaceuticals, Inc., a Delaware corporation with a place of business at 225 South Lake Avenue, Suite 1050, Pasadena, California 91101, USA (“Arrowhead”), and Janssen Pharmaceuticals, Inc., a Pennsylvania corporation with a place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey 08560, USA (“Janssen”) and amends the License Agreement between the Parties dated October 3, 2018. 

 

RECITALS:

 

	

	
WHEREAS, the Parties have entered into a License Agreement, dated as of October 3, 2018, pursuant to which Arrowhead granted Janssen an exclusive license to Develop and Commercialize Licensed Products (the “License Agreement”);

 

WHEREAS, the Parties now wish to amend the License Agreement to create a framework for Arrowhead to provide additional support to Janssen for certain activities in relation to the Licensed Product;

 

WHEREAS, under the License Agreement, Arrowhead is responsible for the conduct and completion of the Ongoing Phase 1/2 Study, which includes the CAM Cohort;

 

WHEREAS, the Parties now wish to agree on the safety data exchange procedures for the CAM Cohort;

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants of the Parties set forth in this Second Amendment, the Parties hereto agree as follows:

 

AGREEMENT:

 

1.Definitions.  Capitalized terms used herein but not otherwise defined herein will have their respective meanings set forth in the License Agreement.

 

	
 
	
2.
	
Amendments to the License Agreement.

 

 

 

2.1.The following definition is added between Sections 1.19 and 1.20 of the License Agreement:

 

“1.19bis“Arrowhead Services” has the meaning set forth in Section 5.14.” 

 

2.2.Section 3.2.1 of the License Agreement is hereby replaced in its entirety with the following:

 

“3.2.1serve as a forum to discuss and monitor the activities under the Clinical Plan and the Arrowhead Services and to approve changes to the Clinical Plan as provided for in Section 5.1.”

 

2.3.The following sentence is added to Section 5.3.2 of the License Agreement:

 

“Arrowhead shall use Commercially Reasonable Efforts to provide the Arrowhead Services.”

 

2.4.The last sentence of Section 5.6.4 of the License Agreement (which was added to the License Agreement by the Amendment No. 1 to the License Agreement entered into by the Parties on 18 December 2018) is hereby replaced in its entirety with the following two sentences:

 

“Notwithstanding the foregoing, the Parties shall not be required to enter into the Pharmacovigilance Agreement in the event that the Ongoing Phase 1/2 Study is fully terminated prior to the initiation of the first clinical study by Janssen for the Licensed Product. The Parties shall comply with the safety data exchange procedures laid down in Exhibit I for the CAM Cohort and Exhibit I shall serve as the pharmacovigilance agreement for the CAM Cohort for as long as Exhibit I has not been superseded by the Pharmacovigilance Agreement.” 

 

2.5. The following section 5.14 is added to the License Agreement:

 

“5.14Arrowhead Services.   Upon request by Janssen, the Parties may negotiate in good faith to enter into a Statement of Work, a template of which is attached to this Agreement as Exhibit J, under which Arrowhead would provide certain services to Janssen in relation to the [**] of any Licensed Product or Licensed Construct on [**] (the “Arrowhead Services”). The Arrowhead Services shall be governed by the terms and conditions of this Agreement, and the terms and conditions of the Statement of Work concerned. In the event of any conflict between the terms and conditions of this Agreement and the terms and conditions of a Statement of Work entered into between the Parties under this Section 5.14, the terms and conditions of the Statement of Work shall prevail.”

 

 

 

2.6.The Appendix 1 (entitled ‘Exhibit I – Safety data exchange procedures for the CAM Cohort) which is attached to this Second Amendment is hereby added as Exhibit I to the License Agreement. 

 

2.7.The Appendix 2 (entitled ‘Exhibit J – Statement of Work Template’) which is attached to this Second Amendment is hereby added as Exhibit J to the License Agreement.

 

3.Term. This Second Amendment shall be effective as of the Second Amendment Effective Date.

 

4.No further changes. Except as specifically modified herein, no changes are made to the License Agreement and the License Agreement remains in full force and effect. This Second Amendment is subject to the terms of the License Agreement. 

 

 

IN WITNESS WHEREOF, the Parties hereto have caused this Second Amendment to be executed by their duly authorized representatives as of the date first above written.

 

 

	
Arrowhead Pharmaceuticals, Inc.
	

 

 

By /s/ Thomas Schluep

 

Print Name Thomas Schluep

 

Title Vice President, Program Management

 

 

 

Janssen Pharmaceuticals, Inc.

 

 

By /s/ Flavia Pease

 

Print Name Flavia Pease

 

Title Vice President Finance and Chief Financial Officer

 

 

 

 

APPENDIX 1 

Exhibit I

Safety data exchange procedure for the CAM Cohort1 

 

[**]

	
	 

 

 

 

APPENDIX 2 

Exhibit J

Statement of Work Template

[**]arwr-ex1021_309.htm

EXHIBIT 10.21

 

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

Amendment #1 to Research 

collaboration and option agreement

 

This Amendment (hereinafter “Amendment #1”), is made, and effective, as of the date of execution by the last Party to sign below (the “Execution Date”), is to the Research Collaboration and Option Agreement having an Execution Date of October 3, 2018 (the “Agreement”), by and between Arrowhead Pharmaceuticals, Inc., a Delaware corporation with a place of business at 225 South Lake Avenue, Suite 1050, Pasadena, California 91101, USA (“Arrowhead”), and Janssen Pharmaceuticals, Inc., a Pennsylvania corporation with a place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey 08560, USA  (“Janssen”).  

WHEREAS, Janssen and Arrowhead find it in their respective interests to modify the Agreement to include a process for conducting validation/preselection work on one or more targets to inform a Janssen decision on whether or not to propose such target(s) as Target(s) under the Agreement;

NOW THEREFORE, in consideration of the foregoing and the agreements below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

1Definitions.  Unless the context otherwise requires, the terms in this Amendment #1 with initial letters capitalized shall have the meanings described below or the meaning as designated in the indicated places throughout this Amendment #1.  All other such terms not otherwise defined herein shall have the meanings ascribed thereto in the Agreement.

1.1 “Target Validation Costs” shall mean FTE Costs and Out-of-Pocket Costs (each analogously applied to work hereunder) incurred by the Parties and their Affiliates following the Effective Date of this Amendment #1, in each case to the extent incurred under the Target Validation Plan. 

1.2 “Target Validation Plan” shall have the meaning as set for in section 2.2 below.

1.3 “Validation Compound Delivery Period” shall mean the period commencing upon the Parties’ mutual agreement in writing of the Target Validation Plan and ending [**] after such agreement.

1.4 “Validation Compounds” shall have the meaning as set for in section 2.2 below.

1.5 “Validation Data and Know-How” shall have the meaning as set forth in section 2.4 below.

1.6 “Validation Selection Period” shall mean the period commencing upon the Parties’ mutual agreement in writing of the Target Validation Plan and ending on the [**] anniversary of such agreement, except that if the agreed upon quantity of any Validation Compounds to be provided by Arrowhead are received by Janssen after the Validation Compound Delivery Period, then the Validation Selection Period shall be automatically extended by one day for each day past the end of the Validation Compound Delivery Period that the agreed upon quantity of such Validation Compound is received by Janssen.

1.7 “Validation Target” shall have the meaning as set for in section 2.1 below.

 

2.Target Validation/Selection.  

2.1 Validation Targets.  Promptly following execution of this Amendment #1, and continuing through the [**] anniversary of the Effective Date of the Agreement, Janssen may, at its own discretion, propose to Arrowhead targets for work under this Amendment #1.  Arrowhead will accept or reject such proposed targets in a process analogous to the process for Target acceptance in Section 4.1.2 of the Agreement, except that Arrowhead shall have an additional right to reject a proposed target for work hereunder if Arrowhead has conducted rodent studies in an active research program against the proposed target.  Such a proposed target that is accepted by Arrowhead will be a “Validation Target” for the purposes of this Amendment 1.  Janssen may propose targets until up to [**] Validation Targets are identified.  For clarity, the terms proposed herein relative to Validation Targets do not amend Janssen’s right to timely select any target that is not a Validation Target as a Target in accordance with Article 4 of the Agreement.  

2.2 Target Validation Plan.  Promptly following the acceptance of a Validation Target, the Parties shall mutually agree to a research plan to be conducted by Arrowhead and Janssen to generate data on such Validation Target to guide Janssen’s selection of Targets (“Target Validation Plan”).  Such Target Validation Plan shall include, on behalf of Arrowhead, an obligation to identify, manufacture, and deliver [**] sRNAi compounds (“Validation Compounds”) to Janssen for each Validation Target, and on behalf of Janssen, a right to conduct model-specific studies to inform its Target selection.  The Parties shall use Commercially Reasonable Efforts to complete the Target Validation Plan.  Arrowhead will use its reasonable judgment, in consultation with Janssen, to select the Validation Compounds based on its determination of their potential effectiveness in modulating the Validation Targets.  Arrowhead will manufacture and deliver to Janssen sufficient quantities of each of the Validation Compounds to complete the agreed model-specific studies.  

2.3 Target Validation Plan Costs.  Janssen will bear all Target Validation Costs for work under the Target Validation Plan.  Such costs shall be reported by Arrowhead and paid by Janssen on a quarterly basis in accordance with a process analogous to that for Research Costs in Section 7.1 of the Agreement.  

2.4 Validation Data and Know-How Sharing.  The Parties will promptly and diligently share all material data and know-how generated in the course of completing work under the Target Validation Plan (“Validation Data and Know-How”) through the JSC or appropriate subcommittee.  The Parties will promptly respond to any reasonable question of the other Party regarding such work or the Validation Data and Know-How.  Validation Data and Know-How shall be deemed the Confidential Information of both Parties under the Agreement and subject to the licenses of each Party to the other under Section 2.1.3 except that the chemical identity of the Validation Compounds will be the Confidential Information of Arrowhead only and the licenses of Section 2.1.3 will not apply to the exploitation of the Validation Compounds.

2.5 Janssen Right to Select Validation Targets.  At any time during the Validation Selection Period, in addition to the rights provided under the Agreement, Janssen shall have the right to: (a) select Validation Targets for inclusion as Targets under the Agreement, and/or (b) replace any Targets previously selected under the Agreement with Validation Targets, in each case, via a Target Proposal in accordance with Section 4.1.2 of the Agreement, with the exceptions under Section 4.1.2 that (i) the allowed time period is the Validation Selection Period and (ii) Arrowhead will not have the right to reject such a Target Proposal.

3.Inventions.  During the Validation Selection Period, the reporting, ownership and patent rights with regard to any inventions arising from work under any Target Validation Plan shall be governed by Article X of the Agreement as if such work were under the Agreement and Validation Compounds were Licensed Constructs.  Upon termination of the Validation Selection Period and as to the Validation Targets not made Targets under the Agreement, then Patents or Inventions subject to this Section will be treated as if such Validation Target was the basis of a Program and the Program is a terminated Program under Section 15.6.2 of the Agreement.  

4.Arrowhead Limited Use of Validation Targets.  Arrowhead shall not collaborate with any third party on any Validation Target during the Validation Selection Period.  For clarity, after the expiration of the Validation Selection Period, this Amendment #1 shall not prevent or place any encumbrance on Arrowhead to develop compounds, including Validation Compounds, directed toward any Validation Target that is not selected as a Target under the Agreement for its own internal or external business purposes.

 

IN WITNESS WHEREOF, each Party has caused this Agreement to be duly executed by its authorized representative on the respective date written herein below.

		
	
 
	
Arrowhead Pharmaceuticals, Inc.

	
 
	
By:/s/ Christopher Anzalone 

Name: Christopher Anzalone                                                                                   Title:   Chief Executive Officer  

Date:   November 14, 2019 

	
 
	
 

Janssen Pharmaceuticals, Inc. 

	
 
	
By:/s/ Jeffrey N. Smith

Name: Jeffrey N. Smith        
Title:   Vice President  

Date:    November 14, 2019

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