Document:

Exhibi 4.49

 

[*] Represents material that has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

 

SECOND AMENDMENT AGREEMENT

This Amendment Agreement (“Amendment Agreement”), dated as of October 16, 2018 (the “Execution Date”), is between the University of Massachusetts (“University”), a not-for-profit, public institution of higher education of the Commonwealth of Massachusetts, established by Chapter 75 of the Massachusetts General Laws, as represented by its Medical School (Worcester campus), and Agalimmune Ltd (“Company”), a private limited company incorporated in England & Wales (company registration number 08504603) with registered address at 1st Floor Thavies Inn House, 3-4 Holborn Road, London, EC1N 2HA, United Kingdom.

WHEREAS University and Company entered into an Exclusive License Agreement effective as of April 30, 2013 and thereafter amended such agreement in a document dated February 6, 2017 (the License Agreement as amended shall be referred to as the “Agreement”).

AND WHEREAS University and Company wish to further amend the License Agreement, with effect from the Effective Date (as defined below).

THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, University and Company agree as follows:

1          Definitions

1.1          “Effective Date” shall mean March 20, 2017.

1.2          Terms defined in the Agreement (including by way of cross-reference), unless otherwise defined herein, have the same meaning herein as if set out in this Amendment Agreement.

2          Amendments to the Agreement.

2.1          Amendment of Section 3.1.  Section 3.1(b) of the Agreement shall be and is hereby replaced as of the Effective Date in its entirety by the following:

3.1(b)      Development of Licensed Products.

(i)           Within [*] days of the Commencement Date, Company shall furnish University with a written business plan under which Company intends as of the Commencement Date to develop Licensed Products.

(ii)          Within [*] days after the start of each calendar year, beginning on January 1, 2014 Company shall furnish University with a written report on progress during the prior year to develop and commercialize Licensed Products, including without limitation research and development, efforts to obtain regulatory approval, marketing, and sales figures.  Company shall also include in the report a discussion of its intended development and commercialization efforts and sales projections for the current year.

 

(iii)         During [*], Company, its Affiliate or Sublicensee shall commence a Phase I clinical trial or its equivalent covering at least one (1) Licensed Product.

(iv)         During [*], Company, its Affiliate or Sublicensee shall commence a Phase II clinical trial or its equivalent covering at least one (1) Licensed Product, should such a trial be required by the FDA.

(v)          During [*], Company, its Affiliate or Sublicensee shall commence a Phase III clinical trial or its equivalent covering at least one (1) Licensed Product.

(vi)         No later than [*], Company, its Affiliate or Sublicensee shall be ready to file a New Drug Application (“NDA”) or Biologics License Application (“BLA”) with the FDA covering at least one (1) Licensed Product.

(vii)        Within [*] months after receiving FDA approval of the NDA or BLA for any Licensed Product, Company, its Affiliate or Sublicensee shall market the approved Licensed Product in the United States.

3          Miscellaneous

3.1          Binding Effect.  This Amendment Agreement is binding upon and inures to the benefit of the parties and their respective permitted successors and assigns and are not intended to benefit, or be enforceable by, anyone else.

3.2          Assignment.  This Amendment Agreement may not be assigned by either party without the prior written consent of the other party, which consent may not be unreasonably withheld or delayed.  Notwithstanding the foregoing, this Amendment Agreement may be assigned by either party in connection with a merger, consolidation, sale of all of the equity interests of the party, or a sale of all or substantially all of the assets of the party to which this Amendment Agreement relates.

3.3          Amendment and Waiver.  The parties may only amend, supplement, or otherwise modify this Amendment Agreement through a written instrument signed by both parties. The waiver of any rights or failure to act in a specific instance relates only to that instance and is not an agreement to waive any rights or fail to act in any other instance.

3.4          Governing Law.  This Amendment Agreement is governed by and construed in accordance with the laws of the Commonwealth of Massachusetts irrespective of any conflicts of law principles.  The parties may only bring legal action that arises out of or in connection with this Amendment Agreement in the Massachusetts Superior Court in Suffolk County.

3.5          Severability.  If any provision of this Amendment Agreement is held invalid or unenforceable for any reason, the invalidity or unenforceability does not affect any other provision of this Amendment Agreement, and the parties shall negotiate in good faith to modify the Agreement to preserve (to the extent possible) their original intent.  If the parties fail to reach a modified agreement within sixty (60) days after the relevant provision is held invalid or unenforceable, then the dispute shall be resolved in accordance with the procedures set forth in Article 9 of the Agreement.  While the dispute is pending resolution, this Amendment Agreement shall be construed as if the provision were deleted by agreement of the parties.

 

3.6          Counterparts.  This Amendment Agreement may be executed in one or more counterparts, each of which is an original, and all of which together are one instrument. A copy of an executed counterpart may be delivered by facsimile or other electronic means and such counterpart so delivered shall be equally effective for all purposes.

3.7          Entire Agreement.  This Amendment Agreement constitutes the entire agreement between the parties with respect to its subject matter and supersedes all prior agreements or understandings between the parties relating to its subject matter.

The parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

 

	UNIVERSITY OF MASSACHUSETTS	AGALIMMUNE LTD.
	 	 
	
By: /s/ James P. McNamara

	
By: /s/  Mali Zeevi

	
Name: James P. McNamara, Ph.D., 

	
Name: Mali Zeevi

	
Title: Executive Director 

	
Title: Chief Financial Officer

	
  Office of Technology ManagementExhibit 4.50

 

[*] Represents material that has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

AMENDMENT NO. 1 TO LICENSE AGREEMENT

THIS AMENDMENT NO. 1 (“Amendment”) is entered into effective as of June 18th, 2018 (the “Amendment Effective Date”) by and between BioLineRx Ltd. (“BioLine”) and Wartner Europe BV (“Perrigo”).

PREFACE:

	A.	
BioLine and Perrigo entered into a License Agreement dated as of December 22, 2014 (the “Agreement”).

	B.	
The Parties now wish to amend certain provisions of the Agreement.

Now therefore, the Parties hereby agree as follows:

	1.	
Section 3.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

		3.1          	a.          	With respect to the Licensed Products referred to in Section 7.2, in consideration for the exclusive license granted to Licensee under Section 2.1, for each Licensed Product unit sold by Licensee and its Sublicensees in a given calendar quarter, Licensee will pay Licensor an amount equal to [*].

		b.	
For the purpose of this Agreement, [*].

	2.	
Subsections (a) and (b) of Section 3.2 are hereby deleted in their entirety and replaced with the following: [*]

	3.	
Section 3.3 is hereby deleted in its entirety and not replaced.

	4.          	(a)          	In Section 4.1, the sentence “Licensor has the right to examine Records that were created within five (5) years of the date of Licensor’s request” is hereby amended to read “Licensor has the right to examine Records that were created within seven (7) years of the date of Licensor’s request.”

		(b)	
In Section 4.2, the reference to “five (5) years” in the second line is hereby amended to “seven (7) years.”

	5.	
In Section 7.2(a), [*]

	6.	
Following the Amendment Effective Date, if Perrigo desires to add one or more countries to the Territory, it shall notify BioLine of such desire, and the Parties shall negotiate in good faith as to whether and on what terms such country(ies) will be added to the Territory.

	7.	
Capitalized terms used but not defined herein shall have the meanings set out in the Agreement.  Except as otherwise specifically agreed in this Amendment, the existing terms of the Agreement shall remain in full force and effect.

	8.	
This Amendment shall be binding upon the parties once executed by all parties and shall enter into force and become effective as of the Amendment Effective Date first written above.

[signature page follows]

IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their duly authorized representatives as of the Amendment Effective Date.

 

	
BioLineRx Ltd.

 

By: /s/ Philip Serlin

 Name: Philip Serlin

 Title: Chief Executive Officer

	
Wartner Europe BV

 

By: /s/ Christophe Van Damme

 Name: Christophe Van Damme

 Title: Director

 

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